데이터베이스 소개
국제 의료기기 데이터베이스 사용법
데이터 다운받기
FAQ
출처표기
Manufacturers
Deroyal Industries, Inc. Lafollette
제조사 주소
Deroyal Industries, Inc. Lafollette, 1501 East Central Ave, La Follette TN 37766-2892
제조사 모회사 (2017)
Deroyal Industries Inc.
Source
USFDA
11 Events
Device Recall GEOMED BASIC CYSTO PACK 의 리콜
Device Recall GEOMED BIOPSY TRAY 의 리콜
Device Recall DeRoyal (R) AMNIOCENTESIS TRAY 의 리콜
Device Recall Episeal wound closure strips 의 리콜
Device Recall Episeal wound closure strips 의 리콜
Device Recall Episeal wound closure strips 의 리콜
Device Recall DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits 의 리콜
Device Recall DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits 의 리콜
Device Recall Circumcision trays and packs 의 리콜
Device Recall Circumcision Clamp 의 리콜
DeRoyal Incision and Drainage Tray 의 리콜
{{ $t('card.reduce') }}
{{ $tc('card.more', left) }}
데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 11 건
Device Recall GEOMED BASIC CYSTO PACK
모델명 / 제조번호(시리얼번호)
REF 50-13272.05; Lot Numbers: 17739282, 18176434, 18472233, 18812517, 19020546, 19187135, 19516744, 20175043, 20429998, 20494394, 20886460, 22346424, 22730047, 22821900, 23335313, 23615260, 24004698, 24338081; REF 89-5721.02; Lot Numbers: 17637745, 18026233, 18026241, 18081398, 18120801, 18120836, 18137363, 18179580, 18270594, 18336750, 18692682, 19052599, 19520209, 19684545, 19703890, 20210291, 20561454, 20893416, 21412776, 21559479, 22188024, 23002893, 23340948, 23534654, 23951183, 24294226; REF 89-6353.03; Lot Numbers: 16174769, 16174793, 16174806, 16407833, 18271167, 18410809, 18497262, 18639208, 18661122, 18867024, 19103261, 20501056, 21186406, 21652702, 22059951, 22124741, 22736713, 23699328, 24075699, 24233677, 24868171; REF 89-6425.03; Lot Numbers: 19569432, 19569459, 19569467, 19623929, 19686014, 19686022, 20502260, 20683970, 20895518, 21113186, 21375258, 21653650, 22021363, 22060434, 22188585, 22319101, 22437431, 22737661, 22924175, 23427461, 23623083, 23880590, 24010895, 24162493, 24578659, 24750594, 24827723; REF 89-6428.01; Lot Numbers: 16808282, 18591611, 18867534, 18966006, 19685476, 20013925, 20040771, 20179255, 20501427, 20894777, 21112933, 21653019, 22020889, 22083361, 22188323, 22506272, 22737020, 23235996, 23535711, 24076018, 24294955, 24578341, 24600617, 24776524; REF 89-6431.03; Lot Numbers: 17885503, 18146825, 18271491, 18411051, 19521041, 19685661, 19778242, 19824819, 20133118, 20179360, 20683460, 21058973, 21375178, 21653297, 22021110, 22188446, 22437246, 22590021, 22737273, 22965031, 23236180, 23236198, 24076237, 24162160, 24600692, 24827230; REF 50-12770.12; Lot Numbers: 17679267, 18007518, 18078455, 18104844, 18495216, 18810706, 19018489, 19186749, 19568595, 19673598, 19727656, 19776191, 20006637, 20173700, 20884270, 21053081, 21529018, 21813019, 21881433, 21978198, 22203811, 22286821, 22412612, 22582822, 22609440, 22821601, 23945445, 24229150, 24427324, 24745082, 25022978; REF 50-13049.13; Lot Numbers: 17634000, 17879841, 18495689, 18812365, 19900463, 20231404, 21054315, 21530211, 21645502, 22082107, 22261957, 22729986, 23198435, 23419488, 23777947, 24428845, 24853981; REF 50-5297.12; Lot Numbers: 17434198, 17902941, 18075895, 18183116, 18408725, 18452056, 18496729, 18496737, 18677440, 19023739, 19419805, 19496704, 19681168, 19901562, 20176901, 20232423, 20678855, 20890573, 21513260, 21648922, 21923568, 22018201, 22082828, 22586858, 22822451, 22938892, 23233202, 23422521, 23532552, 23838199, 24073247, 24158304, 24431770, 24575976, 24854916; REF 50-8069.03; Lot Number 17701102; REF 50-9269.02; Lot Numbers: 17374463, 18108933, 18217259, 18405153, 18495005, 18856691, 19412419, 19672253, 20283909; REF 50-9329.21; Lot Numbers: 18910336, 19023851, 19419987, 19681715, 19828861, 19869970, 20011356, 20232491, 20461154, 20679014, 20758054, 22610547, 22757282, 22822486, 22872547, 23422679, 23532683, 24369064, 24576047, 24775329, 24806789; REF 53-1930.01; Lot Numbers: 24884461, 25014468, 25015428, 25055227; REF 53-1736.06; Lot Numbers: 18118058, 18118066, 18118074, 18272995, 18273015, 18273023, 18339678, 18339686, 18339694, 18421006, 18421014, 18421022, 18539830, 18539848, 18564509, 18564517, 18564525, 18656438, 18656446, 18782004, 18782012, 18782021, 18871023, 18871031, 18871040, 18871058, 18969944, 18969952, 19030736; REF 89-0882.10; Lot Numbers: 17964092, 18074788, 18273912, 18341073, 18405188, 18676631, 19447902, 19672333, 19800294, 20230920, 20882573, 21003711, 21109267, 21314981, 21528058, 21642011, 22231475, 22788783; REF 89-2156.07; Lot Numbers: 17901420, 18074796, 18217304, 18273921, 18495072, 18533551, 18657094, 18809078, 19016707, 19412591, 20004720, 20036924, 20172942, 20491214, 20911928, 21109312, 21642070, 21861408, 22392981, 22727358, 22937611, 23416332, 23775790, 24002393, 24517709; REF 89-2422.11; Lot Numbers: 17615714, 18049857, 18217312, 18341137, 18495099, 18586302, 18809094, 19186474, 19412603, 19672413, 20004771, 20369948, 21052248, 21812331, 21861432, 22013646, 22034877, 22081788, 22581774, 22937638, 23416359, 24287093, 24426410; REF 89-2670.12; Lot Numbers: 17913404, 18214998, 18553674, 18861263, 19068751, 19417181, 19828342, 20008958, 20494968, 21054729, 21385860, 21530641, 21814521, 22140864, 22394012, 22636931, 23055274, 23335727, 23778270, 23873939, 24156296, 24356044, 24429477, 24795389; REF 89-2671.14; Lot Numbers: 17880340, 18176565, 18215000, 18451467, 18620478, 18861271, 19068769, 19187338, 19322405, 19417199, 19676254, 19777004, 20008966, 20231931, 20675911, 20712890, 20782118, 20887155, 20912390, 21004490, 21297552, 22016311, 22394021, 22730637, 22871501, 23188333, 23420008, 23470865, 23693778, 24230329, 24518971, 24662105; REF 89-2688.08; Lot Numbers: 17347676, 18183440, 18474301, 18497019, 18815751, 19044222, 19325825, 19642513, 19881493, 20011751, 21005370, 21457907, 21649597, 22058721, 22100969, 22347101, 24576477; REF 89-2817.07; Lot Numbers: 17964519, 18029725, 18183511, 18183520, 18712743; REF 89-3064.07; Lot Numbers: 17463167, 17617699, 18183909, 18342439, 18474212, 18712567, 19325649, 19881354, 20208781, 21005302, 21056919, 24102984, 24650825; REF 89-3129.02; Lot Numbers: 21649431, 21875543, 22177165, 22347048, 22624308; REF 89-3145.10; Lot Numbers: 17901489, 17974266, 18181524, 18283766, 18405241, 18469878, 18553033, 18586361, 18907831, 18977549, 19050219, 19150578, 19336621, 19447937, 19479058, 19514554, 19672499, 19810038, 19876838, 20204756, 20491329, 20537665, 20672015, 20818504, 20882805, 20954240, 21052299, 21143852, 21182907, 21421138, 21469924, 21642176, 22013718, 22013726, 22122666, 22260954, 22377001, 22434150, 22581871, 22727471, 22780571, 22917725, 23222255, 23416455, 23527817, 23775896, 24002529, 24287165, 24426495, 24572695, 24744274, 24896913; REF 89-3251.08; Lot Number 18008035; REF 89-3179.01; Lot Numbers: 17663337, 17880518, 18176725; REF 89-3423.03; Lot Numbers: 17348273, 17617912, 17643336, 18474431, 19196509, 19326001, 19683147, 20392777, 20498651, 21005425, 21319281, 22018789, 22399454, 24243859; REF 89-3448.03; Lot Numbers: 17481461, 17877520, 18135499, 18349606, 18406252, 18587014, 18858697, 18951841, 19050753, 19414289, 19751875; REF 89-3802.04; Lot Numbers: 17904399, 17904401, 18014081; REF 89-3805.12; Lot Numbers: 17739493, 17780568, 17841906, 17989038, 18456348, 18475240; REF 89-3825.13; Lot Numbers: 17779698, 17988481, 18025821, 18080070, 18177146, 18269219, 18335482, 19021776, 19101311, 19131633, 19322915, 19715410, 20009361, 20325638; REF 89-3861.10; Lot Numbers: 16404894, 17635168, 18861861, 19322958, 20207252, 21004705, 21055115, 24932241; REF 89-4260.08; Lot Numbers: 19022103, 19323344, 19337851, 19517501, 19677142, 20009598, 21647065, 22244452, 22346678, 22981364, 23066571, 23230626, 23779272, 24072076, 24519202, 24575001, 24854457; REF 89-4272.03; Lot Numbers: 17635467, 18155668, 18177550, 18473113, 18862135, 19225402, 20495952, 21947156, 22057665, 22585311, 24006061, 24290903; REF 89-4340.02; Lot Numbers: 17881351, 18177605, 18384760, 18473201, 18559961; REF 89-4401.01; Lot Numbers: 6514997, 17349170; REF 89-4431.04; Lot Numbers: 17477631, 17672209, 17802106, 18029320, 18181778, 18274000, 18525593, 18535484, 18535492, 18659209, 18862266, 19022322, 19101581, 19418263, 19517755, 19801385, 19915761, 20009791, 20207746, 20370498, 20496226; REF 89-4811.07; Lot Numbers: 18474829, 18864595, 19326490, 19519224, 20177858, 20499232, 20758492, 21057541, 21816834, 22019221, 22187638, 22216275, 22414079, 22470708, 22734718, 22922209, 23234256, 23620165, 23950383, 24025641, 24074178, 24253942, 24293338; REF 89-5197.01; Lot Numbers: 15836855, 18178552, 18473949, 19383451, 19518299, 20010492, 21338713, 21686777, 21840084, 22058393, 22732464, 22872230, 23015504, 23189424, 23258987, 23337685, 23532026, 23948777; REF 89-5434.03; Lot Numbers: 17964711, 18077401, 18185912, 18343247, 18691268, 18857029, 19017013, 19318756, 19514722, 19877048, 20491492, 20883111, 21315221, 21642504, 21837133, 22377191, 22917987, 23222651, 23690825.23944784, 24287333, 24517848; REF 89-5579.02; Lot Numbers: 17905623, 18001298; REF 89-5645.01; Lot Numbers: 17857991, 18475531, 18816964, 19120900, 21023957, 21599147, 21651582, 21817263, 21841360, 22059530, 23066985; REF 89-5702.01; Lot Numbers: 17882978, 18179184, 18475670, 18911144, 19026121, 19214851, 19327425; REF 89-5747.04; Lot Numbers: 17883330, 17989476, 18137241, 18270471, 18410104, 18410112, 18536891, 18660496, 18817473, 18896001, 19032969, 19033321, 19033339, 19033347, 19033355; REF 89-5753.03; Lot Numbers: 17781051, 17931549, 18081283, 18137275, 18179432, 18336602, 18475944, 18817529, 18896010; REF 89-5907.01; Lot Numbers: 15560924, 15817321; REF 89-5952.02; Lot Numbers: 17632012, 17679531, 17878151, 17929852, 17987358, 18078834, 18175247, 18268030, 18334316, 18406615, 18406631, 18450958, 18471370, 18534385, 18587276, 18709667, 18859180, 18931356, 19019060, 19050913, 19151642, 19248701, 19414908, 19414916, 19515856, 19878366, 20037687, 20492971, 20673923, 21004043, 21315853, 21470520, 21644235, 21921618, 22014913, 22056443, 22122965, 22272269; REF 89-6003.01; Lot Numbers: 17901761, 18013643, 18182017, 18405524, 18533841, 18857416, 19050374, 19413198, 19590557, 19672907, 19776028, 19877419, 20037206, 20378828, 20537905, 20712241, 20883509, 21052707, 21315360, 21528613, 21837361, 22055862, 22377458, 22727905, 22870509, 23066256, 23223071, 23612739, 24287632; REF 89-6060.02; Lot Numbers: 17347334, 17616119, 18315140, 18405882, 18450624, 18470676, 19050454, 19319281, 20324918, 20491919, 23417167, 23691166, 24821305; REF 89-6071.06; Lot Numbers: 17917966, 17935566, 17973925, 17973933, 18000279, 18029371, 18075300, 18217443, 18274229, 18283918, 18283926, 18341444, 18355408, 18419432, 18450472, 18657369, 19017603, 19413374, 19590581, 19751533, 20006282, 20672736, 20883648, 21109582, 21643021, 22014121, 22215563, 22315960, 22727999, 22780722, 23612835, 24153992, 24337610, 24572986, 24773753; REF 89-6169.02; Lot Numbers: 17867882, 17878813, 17878821, 18146171, 18175896, 18231325, 18334720, 18349868, 18349876, 18407010, 18471695, 18534730, 18691621, 18709991, 18859868, 18931751, 19320830, 19674540, 19800770, 19878593, 20125572, 20206161, 20517832, 20674387, 21183619, 21337340, 21813588, 22015174, 22503725, 23225253, 23418549, 23872506, 24155031, 24288678, 24518470, 24573655, 24745550, 24853649, 24897588; REF 89-6219.01; Lot Numbers: 17879058, 17879066, 17930255, 17987868, 18079255, 18136037, 18176047, 18268574, 18319351, 18334789, 18534781, 18572859, 18587858, 18638070, 18658441, 19019713, 19100837, 19415564, 19674611, 19810636, 20174403, 20493455, 20756681, 21053654, 21337358, 21529624, 21813668, 22015300, 22261711, 22729185, 22849398, 23225510, 23418696, 23692433, 24070521, 24070521, 24229627, 24573719, 24774203; REF 89-6225.03; Lot Numbers: 18176063, 18384591, 18633084, 18676957, 18710115, 19019772, 19051182, 19415610, 20007533, 20240554, 20756690, 21053697, 21529659, 21838347, 22378338, 22729231, 23872750, 24229651, 24573751; REF 89-6256.04; Lot Numbers: 17388857, 17884771, 17932023, 17990160, 18180185, 18271036, 18476613, 18537391, 18866777, 18866793, 18979544, 19027131, 19037276, 19052821, 19121232, 19188867, 19188875, 19215351, 19250430, 19328401, 19544841, 19544850, 19685089, 20132473, 20179028, 20894144, 20957424, 21112853, 21559621, 22124661, 22318597, 22589400, 22736465, 22923359, 23341457, 23621918, 24009827, 24294541; REF 89-6257.05; Lot Numbers: 17932015, 17990151, 18081873, 18137662, 18180177, 18271028, 18337162, 18350851, 18476605, 19037233, 19037241, 19103181, 19423450, 19544833, 19812156, 20132457, 20179001, 20179010, 20326809, 20379433, 20500846, 20540194, 20682539, 20801892, 21112845, 21320556, 21423141, 21458029, 21535899, 21698057, 22059847, 22110665, 22188163, 22264314, 22436913, 22589397, 22923341, 23002957, 23426012, 23535219, 23621897, 23699117, 23879142, 24009801, 24009819, 24019267, 24161546, 24311567, 24750009, 24899671; REF 89-6262.06; Lot Numbers: 17884594, 17990080, 18146817, 18215501, 18337138, 18350834, 18350842, 18410690, 18476550, 18476568, 18497238, 18537341, 18591224, 18633981, 18866726, 19027086, 19027094, 19103157, 19423361, 19481730, 19520524, 19685038, 20013546, 20178957, 20326796, 20430841, 20500791, 20894064, 20894072, 21006022, 21186289, 21305575, 21340143, 21423125, 21535830, 21652438, 21777290, 21841829, 22020512, 22020521, 22124653, 22736385, 22757451, 22822865, 23031459, 23621803, 24075411, 24233511, 24294496, 24577971, 24749972; REF 89-6406.03; Lot Numbers: 17885255, 17932226, 17990477, 18008713, 18082180, 18180610, 18271360, 18350914, 18476859, 18867438, 19027537, 19052978, 19339469, 19423935, 19456294, 19685433,20040755, 20132852, 20210806, 20410390, 20683128, 20894689, 21305701, 21652930, 21817941, 22020854, 22124813, 22318757, 22736967, 22783270, 22923682, 23235937, 23260833, 23342054, 23342054, 23426653, 23622419, 24010262, 24010262, 24075939, 24294867, 24294875, 24578296, 24631042, 24631042, 24650956, 24750295; REF 89-6727.02; Lot Number: 19956248, 20211551, 20327318, 20502673, 21585749, 21777417, 21794655, 22383022, 22924280, 23236526, 23880899, 24295544; REF 89-6564.01; Lot Numbers: 18054365, 18533294, 18585967, 18656964, 18808462, 18856165, 19016192, 19514351, 19671912, 19727541, 19876598, 20004148, 20172627, 20305071, 20490836, 20882160, 21336777, 21641659, 22315652, 22376834, 22434037, 22543639, 22780466, 22917590, 23092930, 23527340, 24286761, 24598211, 25021588; REF 89-6588.01; Lot Number 19036601; REF 89-6598.01; Lot Number 18949366; REF 89-6600.01; Lot Number 19036644; REF 89-6725.01; Lot Numbers: 19956264, 20041176, 20241098, 20502681, 21842590, 22021486, 22060506, 22590401, 22737855, 22924298, 23342978, 24162741, 24295552, 24435421, 24578771, 24827854; REF 89-6797.01; Lot Numbers: 21641392, 22055248, 22375508, 22912941, 23217721, 24064455, 24534082, 24741823; REF 89-6826.01; Lot Numbers: 21412207, 21421015, 21811769, 21836659, 22122463, 22868450, 22912932, 23217712, 23523488, 23864531, 24284642, 24570690; REF 89-6858.01; Lot Numbers: 22431477, 22483496, 22868484; REF 89-6990.01; Lot Numbers: 22244102, 22260022, 22315089, 22376009, 23218192, 23327751, 23686113, 24064914, 24284837, 24819432, 22244102, 22260022, 22315089, 22376009, 23218192, 23327751, 23686113, 24064914, 24284837, 24819432; REF 89-7063.01; Lot Numbers: 22501341, 22719366, 22914065, 23065595, 23328922, 23524739, 23772231, 23866430, 24150142, 24285362; REF 89-7257.01; Lot Numbers: 22392341, 22653715, 22838875, 22957090, 23411451, 23524448, 23607454, 24065491; REF 89-7361.0206; Lot Numbers: 22543428, 22721992, 22869111, 22959458, 23091591, 23525900, 24660556, 24820345, REF 89-7367.01; Lot Numbers: 22502159, 22914911, 23608967, 23867555, 24150871, 24253299; REF 89-7395.04; Lot Numbers: 22801010, 22822929, 23031934, 23236690, 23308569, 23390523, 23623542, 23785251, 24295659, 24855564; REF 89-7429.01; Lot Numbers: 22563146, 22581256, 22723197, 22916095, 23065843, 23220680, 23689082, 24067621, 24286226, 24743482; REF 89-7502.01; Lot Numbers: 22543487, 22635015, 22722303, 22915738, 23027927, 23525993, 23868478; REF: 89-7655.01; Lot Numbers: 24828152, 24833701; REF 94-0268.07: Lot Numbers: 17723310, 17913535, 18269833, 18319757, 18473720, 18862733, 19131721, 19418802, 19480497, 19811225, 19828570, 20409073, 20496744, 20677991, 20889353, 21184742, 21318122, 21338553, 21350683, 21839930, 21923091, 22058238, 22262757, 22317279, 22585986, 22637926, 22732245, 22800130, 23232138, 23531808, 23695343, 23948591, 24006562, 24157635, 24430662, 24575360, 24662586, 24823079; REF 94-0270.06: Lot Numbers: 17152001, 17348329, 18184282, 18621201, 19326692, 19683868, 19715891, 19829222, 19829231, 20539724, 20680971, 20724575, 21350860, 21412661, 21422843, 21697951, 22347304, 22394995, 22436366, 22964353, 23234467, 23424332, 23533942, 24160244, 24243883, 24433177; REF 47-621.08: Lot Number 15408121; REF 50-12772.13: Lot Numbers: 17901315, 18029178, 18074729, 18181364, 18217208, 18283715, 18632946, 18780113, 18908658, 19068312, 19140185, 19248487, 19414457, 19496165, 19673820, 19900041, 20124895, 20492671, 20492680, 20580701, 20627290, 20801737, 20835611, 20884456, 20932850, 20978604, 21109890, 21643881, 22412647, 22412655, 22636368, 22728633, 22821643, 22849355, 23224293, 23333810, 23691861, 24003450, 24070046, 24229299, 24427527, 24427535, 24573381, 24745218, 24853526, 24923061, 25023153; REF 50-10479.10: Lot Number: 17680313, 18214349, 18734441, 18860439, 19541683, 19675198
의료기기 분류등급
General and Plastic Surgery Devices
의료기기 등급
1
이식된 장치?
No
유통
Nationwide Distribution
제품 설명
Kits and Trays containing lubricant: || GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF 50-13272.05, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO PACK PGYBK, V A MED CTR COLUMBIA, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VAMC-NORTHPORT, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED GU TUR BASIN SET PGYBK, V A MED CTR BAY PINES - C, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED ORTHO PACK A&B;, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) CARDIOVASCULAR DRAPE, MERITCARE HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, ST. MARY'S¿MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) MAJOR CYSTO TRAY, BRYAN LGH MED CENTER EAST, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) URETHRAGRAM TRAY 20/CS, NORTH MISSISSIPPI MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PELVIC EXAM TRAY, BAPTIST MEMORIAL OXFORD, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TUR PACK PGYBK 5/CS, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LABOR AND DELIVERY TRACECART (R), KEESLER MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PHASE ONE DELIVERY TRACECART, TALLAHASSEE MEM REGNL CTR-AMT, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, HOLLAND COMMUNITY HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) GU MINOR, MIDDLESEX MEMORIAL HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, ST ANTHONYS HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) T V H TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LTC/LAP TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LAP GYN TRAY, COFFEE REGIONAL MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) RADICAL PROST TRAY PGYBK, HAYS MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) D&C; GYN PACK, HIGH POINTE SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CRYO TRAY PGYBK, MIDTOWN SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, HOUSTON MEDICAL CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, UNIV ARKANSAS MED LITTLE ROCK, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, In
Device Recall GEOMED BIOPSY TRAY
모델명 / 제조번호(시리얼번호)
REF 89-7617.01: Lot Number 23700991; REF 47-003: Lot Numbers: 19930881, 14034148, 15104953; REF 47-094.019: Lot Number 20508661, REF 47-276.13: Lot Numbers: 17602649, 19555209, 20376793, 21093681, 22419187, 22683210, 24979698; REF 47-324: Lot Numbers: 17889221, 18103956, 18198174, 18782311, 19462176, 19930911, 20508688, 20841051, 21885303, 22898544, 23264965, 23909381, 24461442, 24721435, 24826376, 24870174, 24926879, 25051242; REF 47-327: Lot Numbers: 17830692, 18507723, 20434261, 20504978, 20689600 20796333; REF 47-483: Lot Numbers: 14128591, 18477552, 18871373, 19042121, 19251900, 19990972, 20189171, 20795058, 21097260, 24023557, 24095500, 24174697, 24203283, 24248043, 24808987; REF 47-491.12: Lot Numbers: 17784008, 18987974, 21361438, 22373001, 22772933, 22947297; REF 47-600: Lot Numbers: 17094939, 17217214, 17243463, 17538026, 17738634, 18550713, 18982727, 19491612, 20576681, 20597545, 20779787, 20873001, 21667226, 22195671, 22830380, 23278187, 24059576, 24220391; REF 47-626: Lot Numbers: 17227623, 17295327, 18507766, 18521306, 19310383, 19930953, 20503570, 21092194, 21521083, 22373043, 23251232, 23904248; REF 47-670.05: Lot Numbers: 17022468, 17390957, 18563750, 18755903, 19668318, 19930961, 21474248, 21617051, 22142755, 24310871; REF 47-743.01: Lot Numbers: 17841990, 18452507, 19327100, 19703814, 20178308, 21924659, 22354192, 22900561, 24311516, 24663458, 24924136; REF 47-777.02: Lot Numbers: 17594853, 17832541, 18987982, 19010591, 19313040, 19584712, 21339177, 21821158, 22934681, 23705839, 23846199, 24809496; REF 50-3474.02: Lot Numbers: 18588210, 19507080; REF 89-3899.01: Lot Numbers: 17880972, 18177197, 18691938, 18710967, 18909781, 19021821, 19213727, 19323002, 19517270, 19879799, 20009395, 20207308, 20495637, 21055140, 21317453, 21827031, 21839201, 22057382, 22731285, 22849558, 23336324, 23531023, 23778991, 24005738, 24746747, 24822480; REF 89-6306.02: Lot Numbers: 17682829, 17781843, 17884746, 19328381, 19569264, 19845329, 19883659, 20013571, 20371095, 20894128, 21500557, 21687016, 21841853, 22059839, 22736449, 23621889, 23879134, 24009798, 24294533, 24521222; REF 89-7650.01: Lot Number 24631085; REF 47-746.04: Lot Numbers: 17283351, 17537736, 17669261, 17796391, 18493296, 18750635, 18958621, 18982583, 19407302, 19690523, 20547257, 20597916, 20662280, 20936851, 21149437, 21544832, 21666944, 21707355, 21775500, 23074715, 23683203; REF 47-501: Lot Numbers: 18507758, 18521293, 18624479, 19555225, REF 47-004: Lot Numbers: 22898536, 17138831, 18755831, 20697511, 21116791; REF 47-751: Lot Numbers: 18429569, 19668529
의료기기 분류등급
General and Plastic Surgery Devices
의료기기 등급
1
이식된 장치?
No
유통
Nationwide Distribution
제품 설명
Kits and Trays containing alcohol swabstick/prep pad: || GEO-MED BIOPSY TRAY, V A MED CTR MARTINSBURG, REF 89-7617.01 || Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) ST TPN/CVC DRG KIT W/VAD, REF 47-003, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TPN/CVC Dressing Change Kit, REF 47-094.019, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TPN/CVC DRG CHG KIT, REF 47-276.13, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST CEN LINE KIT, REF 47-324, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST PED TRAY, REF 47-327, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST MAYO CLINIC PICC KIT, REF 47-483, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST PICC DRG CHG KIT, REF 47-491.12, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST IHC DRG CHG KIT, REF 47-600, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, Made in the Dominican Republic; DeRoyal (R) PRESBYT PIC KIT-NICU, REF 47-626.10, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST NEONATAL DRG CHG KIT, REF 47-670.05, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW PREP TRAY, UNIV OF ROCHESTER, REF 47-743.01, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; || DeRoyal (R) St. Central Line Kit, REF 47-777.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; || DeRoyal (R) ARTERIAL LINE HYPER TRAY-25C, UNIV VIRGINIA CHARLOTTESVILLE, REF 50-3474.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW BIOPSY, UNIVERSITY OF WASHINGTON, REF 89-3899.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BIOPSY TRAY, PARKWAY RADIOLOGY, REF 89-6306.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ARTERIAL LINE TRAY, ERLANGER MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST DRESSING CHANGE KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST DIALYSIS KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TRN/CVC DRG KIT W/TRANS, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CVC Dressing Change Kit, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA
Device Recall DeRoyal (R) AMNIOCENTESIS TRAY
모델명 / 제조번호(시리얼번호)
REF 50-11656.02: Lot Number 19321517
의료기기 분류등급
General and Plastic Surgery Devices
의료기기 등급
1
이식된 장치?
No
유통
Nationwide Distribution
제품 설명
Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R) AMNIOCENTESIS TRAY, LINK DREW LACO HOSP, REF 50-11656.02, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA.
Device Recall Episeal wound closure strips
모델명 / 제조번호(시리얼번호)
REF 46-202N, Lot Numbers: 26835591 and 25191755; REF 46-204N, Lot Numbers: 28084357, 28075961, 27003412, 27749425, 27392690, 26036749, 25731731, and 25235543; REF 46-214N, Lot Numbers: 27507573, 27437325, 26970419, 26970275, 26641033, 26394853, 26094578, 26009222, 25621209, 25235800, 25241960, 25120957, 25068811
의료기기 분류등급
General and Plastic Surgery Devices
의료기기 등급
1
이식된 장치?
No
유통
Worldwide Distribution -- USA (nationwide)
제품 설명
Non-sterile wound closure strips, packaged as follows: || DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-202N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-204N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-214N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849
Device Recall Episeal wound closure strips
모델명 / 제조번호(시리얼번호)
REF 47-483, Lot Numbers: 27449271, 27199769, 26706212, 25465699, 25573374, 25750861, 25043496, 24808987; REF 47-491.12, Lot Numbers: 25402954, 25313425; REF 47-626.10, Lot Numbers: 27200029, 25573420, 25465752, 25750844, 25448039; REF 47-732.03, Lot Numbers: 27449300, 26140642, 26023315, 25573876, 24525899; REF 47-787.00, Lot Numbers: 27617924, 26733317, 25574596, 25362737, 25223251; REF 50-7104.05, Lot Numbers: 27559242, 27370028, 26754601, 26136539, 25490325; REF 50-7195.12, Lot Numbers: 27488798, 26742619, 26597992, 26414922, 26314711, 26270324, 26010477, 25893511, 25608717, 25369349, 25159165, 24832987, 24741575; REF 50-9786.03, Lot Numbers: 27489150, 27181278, 26676261, 26415634, 26599445, 26367361, 25609306, 25529701, 25358172, 25369533, 25024543; REF 50-12421.10, Lot Numbers: 26115201, 25697801, 25609031; REF 50-12892.09, Lot Numbers: 27473705, 27123297, 26971008, 26743099, 26384444, 26016941, 25609066, 25490165, 25357882, 25099537, 24853913; REF 50-12898.07, Lot Numbers: 27692561, 27489395, 27181850, 26863103, 26676981, 26280709, 26018760, 25558692, 25358560, 25100198, 24898599, 24747521; REF 50-12892.09, Lot Numbers: 27855439, 27425480, 27181391, 26801375, 26394440, 26385009, 26115703, 24795522, 24662674; REF 70-10770.05, Lot Numbers: 27473713, 26278810, 26017249, 25308108, 25044931; REF 70-1911.20, Lot Numbers: 27728448, 26801084, 26497676, 26384639, 26017257, 25609314, 25358181, 25099836; REF 89-0323.06, Lot Numbers: 24746229, 24684662; REF 89-1918.07, Lot Numbers: 27609721, 27244718, 27180603, 26870768, 26813624, 26676341, 26384663, 26166771, 26017345, 25415341, 25099895, 25024631; REF 89-2176.09, Lot Numbers: 26384698, 26115439, 26062891, 25839574, 25764496, 25609381, 25358261, 25099932, 24662041; REF 89-2703.08, Lot Numbers: 27287005, 26923532, 26115973, 25610008, 25397593, 24898775, 25086031, 25100649; REF 89-2995.10, Lot Numbers: 27473756, 26840649, 25396911, 25024851, 24746421; REF 89-3053.1111 and 89-3053.10, Lot Numbers: 27890710, 27854997, 27776474, 27824528, 27750821, 27588781, 27470310, 27223482, 26839921, 26783648, 26662088, 26398053, 26015420, 25876421, 25697406, 25594693, 25529103, 25396312, 25458894, 24897393, 25272820, 25141766, 24833234, 24661604; REF 89-3190.10, Lot Numbers: 27473473, 27226667, 26956561, 26784430, 26475688, 26279100, 25697879, 25340095, 25201984, 25024957, 24746481; REF 89-3338.11, Lot Numbers: 27078369, 26980588, 26957724, 26785221, 25597034, 25086103, 24898804, 24855134; REF 89-3351.07, Lot Numbers: 27197149, 26957732, 26729289, 26437972, 26394458, 26099037, 25878830; REF 89-3452.07, Lot Numbers: 25255245, 25308204; REF 89-3472.08, Lot Numbers: 27692406, 27227336, 26368612, 24775601; REF 89-3482.06, Lot Numbers: 25086200, 25027533, 24650868; REF 89-3559.11, Lot Numbers: 27487218, 27342668, 27758487, 27286053, 26728091, 26279290, 26609877, 26125371, 25877458, 25459740, 25647396, 25415392, 25308255, 25220843, 25142291, 24898126, 24746579; REF 89-3561.09, Lot Numbers: 27826064, 27648421, 27472711, 27408621, 27342684, 27286070, 27206332, 26956705, 27100335, 26784528, 26663241, 26578679, 26398504, 26279329, 26098190, 26017759, 25816743, 25647409, 25459758, 25340271, 25273507, 25142304, 25025132, 25025124, 24774705; REF 89-3565.12 and 89-3565.13, Lot Numbers: 27610108, 27474345, 27425594, 27286942, 26801527, 27182043, 26664374, 26207931, 26063739, 25597376, 25460679, 25309063, 25203197; REF 89-3564.06, Lot Numbers: 26958129, 26610114, 26553404, 26385367, 26437999, 25879277, 25648006, 25558916; REF 89-3831.10, Lot Numbers: 27649328, 27409033, 26956799, 26922821, 26728180, 26367652, 26098245, 25340360, 25084909; REF 89-3896.07, Lot Numbers: 25340394, 25220886, 24822498, 24806720; REF 89-4003.04, Lot Numbers: 27758541, 27472884, 27498363, 27226122, 27180283, 26956852, 26345031, 26017919, 25816786, 25764576, 25596015, 25025335, 24898214, 24854393, 24774828; REF 89-4049.01, Lot Numbers: 25839700; REF 89-4087.02, Lot Numbers: 25876439, 25458923, 24915301; REF 89-4150.05, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4185.08, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4195.08, Lot Numbers: 27360882, 26077532, 25339174, 25121159; REF 89-4270.06, Lot Numbers: 27689629, 26955665, 26726934, 26366633, 25876501, 26097154, 26277104, 25839339, 25594749, 25697465, 25083674, 24821575; REF 89-4712.09, Lot Numbers: 24599943, 25027710, 25027728, 25143227, 25342007, 25460601, 25597237, 25698521, 25745949, 25879058, 26020026, 26281699, 26398969, 26579073, 26664251, 26785361, 27181649, 27181657, 27197157, 27286838, 27370044, 27474193, 27759076, 27869195, 27903074, 27911752; REF 89-4932.03, Lot Numbers: 27225841, 26956001, 26727321, 25876914, 25339668, 25159499; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-4990.02, Lot Numbers: 27968433, 27636050, 27473182, 27226405, 26728817, 26957370, 26648850, 26368225, 25878258, 25596533, 25558545, 25341101, 25369584, 25085557; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-5032.01, Lot Numbers: 27758292, 27244523, 27542272, 27035271, 26820613, 26985952, 26781562, 26270383, 26384057, 26166033, 26010573, 26077209, 25893562, 25873748, 25763717, 25414859, 25159202, 24741639, 24772347; REF 89-5059.01, Lot Numbers: 27892037, 27867886, 27825029, 27757759, 27741693, 27699376, 27589476, 27527355, 27527371, 27499198, 27407636, 27341446, 27285085, 27224354, 27178378, 26783031, 26800823, 26921182, 26954718, 26783023, 26725827, 26725819; REF 89-5102.03, Lot Numbers: 27700357, 26648876, 26078050, 26037910, 25866450, 25732849; REF 89-5103.03, Lot Numbers: 27648801, 27590522, 27528446, 27499260, 27310498, 27226325, 27100626, 26841078, 26663726, 26345306, 25698214, 25308511, 25142697, 24823108; REF 89-5173.01, Lot Numbers: 26821069, 26280451, 26018559, 25839849, 25698265, 25558617; REF 89-5228.07, Lot Numbers: 26764404, 26704321; REF 89-5259.05, Lot Numbers: 25142814, 25221011, 24974150; REF 89-5293.07, Lot Numbers: 27970306, 27846524, 27206586, 27182431, 26923735, 26821122, 25916736, 25817682, 25397809, 25028181, 24899217; REF 89-5341.01, Lot Numbers: 27221786, 26813472, 25893925, 25141475; REF 89-5383.04, Lot Numbers: 27697901, 27635807, 27385887, 27283397, 27310324, 27034420, 26955083, 26870602, 26726230, 26783373, 26632014, 26565296, 26226956, 26136256, 26090770, 25082946, 24820943; REF 89-5488.02, Lot Numbers: 26096813; REF 89-5545.02, Lot Numbers: 27174828, 26980668, 25879541, 25597632, 24916216, 24824653; REF 89-5559.08, Lot Numbers: 27140126, 26366246, 26726424, 25876041, 25594247, 25415077, 25022249; REF 89-5562.03, Lot Numbers: 27635831, 26986912, 26870611, 26366254, 26096848, 25916402, 25022257, 24953113, 24773690; REF 89-5565.03, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5655.01, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5657.04, Lot Numbers: 27220556, 26923815, 26369236, 26099635, 35242576; REF 89-5687.01, Lot Numbers: 27697531, 26345939, 26090921, 25597721; REF 89-5711.02, Lot Numbers: 27220652, 26958532, 26730212, 26566061, 25879681, 25840479, 25559089; REF 89-5820.01, Lot Numbers: 27467962, 27155598, 26726985, 26366668, 26062541, 25816233, 25529242, 25339246, 25099406; REF 89-5901.02, Lot Numbers: 25339220, 25307754, 25083711, 24853614; REF 89-6211.01, Lot Numbers: 27499067, 24821815; REF 89-6234.03, Lot Numbers: 27902514, 27643268, 27369668, 27175193, 26783875, 26366879, 26277585, 25697596, 25307826, 25084010, 24923192, 24598861; REF 89-6344.02, Lot Numbers: 27339371, 27175450, 26785900, 26665035, 26566117, 26651397, 26021281, 25648461, 25531676, 25398211, 25359044, 25309397, 25203816, 25143972, 24916371, 24826430; REF 89-6397.04, Lot Numbers: 27423450, 26399435, 25880171, 25598272, 25343261, 25087819, 25029766; REF 89-6478.03, Lot Numbers: 27889866, 27608964, 27525771, 27468623, 27221655, 26842450, 26730870, 26476541, 26283811, 25880454, 25648612, 25343472, 25490632, 25030071, 24750455, 24663984; REF 89-6509.01, Lot Numbers: 27339581, 26275467, 25838985, 25696921, 25557112, 25338112; REF 89-6642.03, Lot Numbers: 27787528, 27698111, 26675381, 26726686, 26344311, 25083421, 25338948, 24853446; REF 89-6671.01. Lot Numbers: 27222607, 27688896, 26100325, 26369973, 25880569, 25575919; REF 89-6724.01, Lot Numbers: 26284363, 25880737, 25294375, 25699356, 25088299, 24827838, 24750711, 24776760; REF 89-6814.03, Lot Numbers: 27902688, 27222834, 26094842, 25974215, 25777916, 25649738, 25019197, 24964568; REF 89-6816.03, Lot Numbers: 27255450, 27197026, 27176794, 26800778, 26723645, 26660058, 26394167, 26364021, 26314753, 26314745; REF 89-6830.05, Lot Numbers: 27750805, 27526782, 27340751, 27244195, 27197034, 27177367, 26952958, 26813261, 26781669, 26583700, 26061101, 26061098; REF 89-6844.02, Lot Numbers: 26364064, 26094922, 25080684, 25019234, 24922579; REF 89-6981.03, Lot Numbers: 27177375, 26836842, 26396921, 26660251, 26011120, 25080924, 24597260; REF 89-7061.01, Lot Numbers: 27757054, 27340419, 27176989, 26820656, 26660470, 26364494, 26095095, 25814959, 25592794, 25336977, 25019761; REF 89-7063.01, Lot Numbers: 27931139, 27178360, 26886276, 26820752, 26763997, 26724568, 26643186, 26565018, 26474503, 26397181, 26343722, 25748795, 25457841, 25268100; REF 89-7072.02, Lot Numbers: 27757071, 27645204, 26724242, 26396998, 26011533, 25744170, 24571140; REF 89-7112.01, Lot Numbers: 28036671; REF 89-7158.01, Lot Numbers: 27757986, 27699641, 26764041, 26725405, 26598485, 26166279, 24597964; REF 89-7449.02, Lot Numbers: 27868117, 27845505, 27868109, 27527611, 27407943, 27285376, 27224821, 26921043, 26782813, 26661157, 26674821, 26644365, 26474888, 26365526, 26114823, 26096223, 26013475, 26013467, 25875137, 25696761, 25593535, 25506833, 25395811, 25337806, 25337793, 25255000, 25021191, 25140966, 24952541; REF 89-7462.03, Lot Numbers: 27224047, 26838856, 26725528, 26365518, 26096207, 25271915, 25140958, 25021174, 25021158, 24896454, 24852902, 24820441; REF 89-7549.02, Lot Numbers: 27757732, 27471030, 26783103, 26693116, 26437817, 26275205, 26147713, 26042330, 26014048, 25875330, 25593703; REF 89-7613.01, Lot Numbers: 27868512, 27776888, 27825889, 27700111, 27758372, 27670696, 27472403, 27342473, 27285940, 27179848, 26731362, 26652429, 26370296, 26284620, 26136803, 26064416, 26022380, 26022371, 25944622, 25840831, 25765341, 25699410, 25088475, 25030804, 24649883; REF 89-7646.02, Lot Numbers: 27776896, 27656501; REF 89-7688.01, Lot Numbers: 25438130, 26097648; REF 89-7693.02, Lot Numbers: 26956166, 26922151, 26784069, 26727451, 26662635, 26662651, 26647048, 26344741, 26278123, 25647151, 26016537, 26016545, 25595389; REF 89-7758.01, Lot Numbers: 27609035, 27636826; REF 89-7871.01, Lot Numbers: 27911947, 27951818, 27962912, 28069245, 28076681; REF 89-7762.01, Lot Number: 27468981; REF 89-7768.01, Lot Numbers: 27930662, 27823701, 27469079, 27176153, 27176145; REF 89-7880.01, Lot Number: 28016899; REF 89-7896.01, Lot Number: 27993891; REF 89-6317.02, Lot Numbers: 27823269, 27525510, 27339143, 27221153, 27175222, 26842177, 26730491, 26579591, 26664981, 26498871, 26369551, 26099969, 25866581, 25818028, 25648436, 25531633, 25398182, 25203761, 25087561, 25029512, 24826384, 24750050; REF 89-6371.03, Lot Numbers: 27468463, 26958938, 26730634, 26665123, 26566150, 26369682, 25880147, 25793289, 25598256, 25029723, 24855450, 24750228; REF 89-6432.01, Lot Numbers: 27468501, 27175521, 26730773, 26638897, 26438043, 25029926, 25598344; REF 89-6501.02, Lot Number: 27964281; REF 89-6609.04, Lot Numbers: 27222560, 26366457, 26315721, 26096952, 25876287, 25396232, 25201327; REF 89-6643.01, Lot Numbers: 26344346, 26437876, 26147991, 25876279, 25022652, 25594554; REF 89-6717.02, Lot Numbers: 24643625, 24643617; REF 89-7900.01, Lot Numbers: 27981460, 27981494, 28016813, 28039
의료기기 분류등급
General and Plastic Surgery Devices
의료기기 등급
1
이식된 장치?
No
유통
Worldwide Distribution -- USA (nationwide)
제품 설명
Sterile sterile surgical kits containing Episeal products, packaged as follows: || DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PICC DRESSING CHANGE KIT, REF 47-491.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PICC KIT-NICU, REF 47-626.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ST CENTRAL LN DRUG CHG KIT, REF 47-732.03, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NICU PICC LINE KIT, REF 47-787.00, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ORAL IMPLANT TRAY, REF 50-7104.05, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal A-LINE/CENTRAL LINE PLACEMENT, REF 50-7195.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal STEREO BREAST BIOPSY TRAY, REF 50-9786.03, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal BASIC BIOPSY TRAY, REF 50-12421.10, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAP CHOLE TRAY, REF 50-12892.09, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal KNEE ARTHROSCOPY TRAY, REF 50-12898.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal NEURO SPINE PACK, REF 50-13252.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal BREAST BIOPSY TRAY, REF 70-10770.05, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ANGIOGRAM TRAY-4/CASE, REF 70-1911.20, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal DIAGNOSTIC LAP BASIN, REF 89-0323.06, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PLASTICS TRAY, REF 89-1918.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAP TUBAL VALUE SET, REF 89-2176.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal PACEMAKER TRAY, REF 89-2703.08, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAP GYN, REF 89-2995.10, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal EXTREMITY TRAY, REF 89-3053.11 and 89-3053.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal SHOULDER ARTHROSCOPY TRAY, REF 89-3190.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal ENT EAR TRAY, REF 89-3338.11, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal CHILD CENTRAL LINE, REF 89-3351.07, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal SHUNT TRAY, REF 89-3452.07, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAMI/DISC PACK, REF 89-3472.08, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal LAPAROTOMY TRAY, REF 89-3482.06, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 || DeRoyal MINOR INTERVENTIO
하나 더 6 건 더
Language
English
Français
Español
한국어