Devices

Device Recall OPHTHALMIC PACK

  • 모델명 / 제조번호(시리얼번호)
    Code:9001933 Lots: 140814975 exp. 6/30/17 140513118 exp. 6/30/17 141216436 exp. 12/31/15 150116975 exp. 1/31/16 150116781 exp. 2/28/16 150518667 exp. 5/31/16 150619226 exp. 6/30/16
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Only in Puerto Rico.
  • 제품 설명
    OPHTHALMIC PACK 6/CS || 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 2 건

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Device Recall OPHTHALMIC PACK
  • 모델명 / 제조번호(시리얼번호)
    Code:9001780 Lots: 141015756 exp. 9/30/16 141216419 exp. 12/31/16 150116978 exp. 2/28/16 150317700 exp. 4/30/16 150317701 exp. 4/30/16 150317702 exp. 4/30/16 150518592 exp. 6/30/16 150518593 exp. 6/30/16 150518594 exp. 6/30/16 150518594 exp. 6/30/16
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Only in Puerto Rico.
  • 제품 설명
    OPHTHALMIC PACK 6/CS || 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 Ophthalmic Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers:   87223 88773 89837 95552 97215 97765 100154 100984 102837
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
  • 제품 설명
    Ophthalmic Pack, Part number WAL1107(A and WAL1190 || Product packaged in a convenient manner for use in a general clinical procedure
  • Manufacturer
    Windstone Medical Packaging, Inc.