Devices

Device Recall Belzer UW & Waters IGL Cold Storage Solution

  • 모델명 / 제조번호(시리얼번호)
    UDI 00810805000163, and UDI 00810805000071.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Europe.
  • 제품 설명
    Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. || Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.
  • Manufacturer
    Preservation Solutions, Inc.
  • 1 Event

제조사

Preservation Solutions, Inc.
  • 제조사 주소
    Preservation Solutions, Inc., 1099 Proctor Dr, Elkhorn WI 53121-2027
  • Source
    USFDA