Acumed LLC

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  • 모델명 / 제조번호(시리얼번호)
    Lot code 203214
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including FL, GA, MI, MN, NY, TX, VA and countries of United Kingdom, Herzeles, South Korea, South Africa, China, and Milan
  • 제품 설명
    Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR || Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal.
  • 모델명 / 제조번호(시리얼번호)
    Lot W67385, Model #30170320-S, expiration 8/2010 (two side labels correctly state 30170320-S, Lot W67385; top label may incorrectly state 30170060-S, lot W67391).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA and South Africa.
  • 제품 설명
    Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Distributed by: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124. || The Acumed resorbable fixation devices are designed to provide fixation of specific fractures, osteotomies, and arthrodeses while they heal.
  • 모델명 / 제조번호(시리얼번호)
    Work order number/Lot: W59192 (W=work order, ###=sequential number); Expiration date: 2015-01 (Year/Month)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution --- including states of AR, CA, PA, GA, KS, MO, and TN.
  • 제품 설명
    Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ".
  • 모델명 / 제조번호(시리얼번호)
    50.0 mm Tension Band Pin: Lot 243639 70.0 mm Tension Band Pin: Lots 241127, 242707, 243325, 243948. 90.0 mm Tension Band Pin: Lots 241128. 242708, 243327, 243949.  50.0 mm Tension Band Kit: Lots 216769, 217002, 217941, 219145, 219402, 222732, 223007, 224312, 229889, 232575, 235490, 237772, 244800, 246204, 247056.  70.0 mm Tension Band Kit: Lots 210290, 211349, 214574, 215405, 217004, 218273, 219230, 220978, 221503, 223008, 223477, 224066, 225554, 227193, 229394, 230287, 230952, 231971, 233742, 235502, 237773, 240512, 241185, 243617, 243945, 244801, 246777, 246779, 246938, 247108, 247109, 247493.  90.0 mm Tension Band Kit: Lots 215053, 217005, 218600, 218700, 221465, 222731, 223009, 223756, 225555, 228951, 231573, 236969, 237774, 243620, 244802, 246939, 246990, 247381.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
  • 제품 설명
    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. || 50.0 mm Tension Band Pin; Part Number 30-0097 || 70.0 mm Tension Band Pin; Part Number 30-0098 || 90.0 mm Tension Band Pin; Part Number 30-0099 || 50.0 mm Tension Band Kit; Part Number TB-1550K-S || 70.0 mm Tension Band Kit; Part Number TB-1570K-S || 90.0 mm Tension Band Kit; Part Number TB-1590K-S || Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
  • 모델명 / 제조번호(시리얼번호)
    2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281.  2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261.  8, 7 hole SS compression plate: Lot # 300381.  10, 9 hole SS compression plate: Lot # 299641.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
  • 제품 설명
    The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . || 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S || 2.0 mm SS Sleeve Only; Part Number 01-0022-S || 8, 7 hole, SS compression plate; Part Number 02-2007-S || 10, 9 hole, SS compression plate; Part Number 02-2009-S || Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures
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