Devices

Drill Bits

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
  • 제품 설명
    Drill Bits || Model #'s: || DEP14043 || MIC8053-019 || RIC21-0438 || RIC21-0439 || RIC21-0441 || RIC21-0442 || RIC71173504 || RIC71173505 || RIC71631117 || SMI21-0445 || STR5800-4-125 || STR60-13570 || SYN03.010.060 || SYN03.010.061 || SYN03.010.101 || SYN310.19 || SYN310.24 || SYN310.25 || SYN310.288 || SYN310.31 || SYN310.35 || SYN310.431 || SYN310.44 || SYN310.63 || SYN310.65 || SYN310.66 || SYN310.67 || SYN315.28 || SYN315.40 || SYN315.92 || SYN317.861 || SYN317.871 || SYN356.982 || SYN357.407 || ZIM00-2318-020-00 and || ZIM5056-146 || An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
  • Manufacturer
    Sterilmed Inc
  • 1 Event

제조사

Sterilmed Inc
  • 제조사 주소
    Sterilmed Inc, 11400 73rd Ave N Ste 100, Osseo MN 55369-5562
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA

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Instruments - Drill bits
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: S -0088, S -0089, S-0090, S -0091
  • Manufacturer
    CareFusion Inc
drill bits for omeralis aequalis nails
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    md
  • Manufacturer
    TORNIER
Device Recall Cannulated Drill Bits
  • 모델명 / 제조번호(시리얼번호)
    Part Number  310.65 310.67 310.221  lot numbers  PE00966  PE01000 PE01039 PE01058 PE00959  PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971  PE01059 PE01040
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Canada.
  • 제품 설명
    3.2 mm Cannulated Drill Bit/ QC 170 mm || 2.7 Cannulated Drill Bit/ QC 160 mm || 2.0 mm Cannulated Drill Bit / QC 150 mm || there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
  • Manufacturer
    Synthes, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 63562129, 63578148, 63377521, 63398755, 63415317, 63431736, 63438195, 63438272, 63444661, 63462322, 63474385, 63485128, 63497202, 63505360, 63510813, 63524432 & 63530407.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • 제품 설명
    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 63545279, 63610791, 63641572, 63333729, 63333730, 63333732, 63340531, 63364064, 63364065, 63372902, 63384626, 63384629, 63444670, 63444671, 63457776, 63457945, 63462343, 63462344, 63474390, 63497205, 63497206, 63505362, 63510815, 63535517, 63535518 & 63722007.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • 제품 설명
    ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
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