Devices

Device Recall Customed

  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15170 (150619367) 30-JUN-16 SL15170 (150619366) 30-JUN-16 SL15170 (150619364) 30-JUN-16 SL15170 (150619365) 30-JUN-16 SL15187 (150719668) 31-JUL-16 SL15191-01 (150719669) 31-JUL-16 SL15191-01 (150719670) 31-JUL-16 SL15191-01 (150719667) 31-JUL-16 SL15211 (150720120) 31-JUL-16 SL15211 (150720142) 31-JUL-16 SL15211 (150720122) 31-JUL-16 SL15212 (150720143) 31-JUL-16 SL15212 (150720142) 31-JUL-16 SL15212 (150720121) 31-JUL-16 SL15215 (150720122) 31-JUL-16 SL15215 (150720141) 31-JUL-16 SL15215 (150720121) 31-JUL-16 SL15222 (150720120) 31-JUL-16 SL15233 (150820566) 31-AUG-16 SL15233 (150820568) 31-AUG-16 SL15240 (150820569) 31-AUG-16 SL15243 (150820567) 31-AUG-16 SL15243 (150820566) 31-AUG-16 SL15245 (150820698) 31-AUG-16 SL15245 (150820697) 31-AUG-16 SL15245 (150820696) 31-AUG-16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 900176 || LAPAROTOMY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
  • 1 Event

제조사

Customed, Inc
  • 제조사 주소
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • 제조사 모회사 (2017)
    Customed Inc
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 331 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15202 (150719846) 31-JUL-16 SL15203 (150719846) 31-JUL-16 SL15229 (150820299) 31-AUG-16 SL15231 (150820299) 31-AUG-16
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 9002609 || ARTHOSCOPY PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15212 (150719962) 31-JUL-16 SL15274 (150920990) 30-JUN-16 SL15274 (150920989) 30-SEP-16
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 9002614 || HIP AND KNEE REPLACEMENT SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15181 (150619402) 30-JUN-16 SL15184 (150619402) 30-JUN-16 SL15184 (150619265) 30-JUN-16 SL15274 (150820300) 30-SEP-16 SL15275 (150820301) 30-SEP-16 SL15275 (150820300) 30-SEP-16
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 9002615 || EXTREMITY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15177 (150619477) 30-JUN-16 SL15181 (150619477) 30-JUN-16 SL15212 (150719843) 31-JUL-16 SL15215 (150719843) 31-JUL-16 SL15219 (150719843) 31-JUL-16 SL15271 (150920812) 30-SEP-16
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 9002618 || OPEN HEART SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • 모델명 / 제조번호(시리얼번호)
    LOTS: SL15201-02 (150619403) 31-JUL-16 SL15201-02 (150619266) 31-JUL-16 SL15202 (150619403) 31-JUL-16 SL15208 (150619403) 31-JUL-16 SL15232 (150820302) 31-AUG-16 SL15243 (150820302) 31-AUG-16 SL15246 (150820303) 31-AUG-16 SL15251 (150820303) 31-AUG-16
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed only in Puerto Rico.
  • 제품 설명
    Catalog Number: 9002726 || HIP AND KNEE REPLACEMENT SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
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