PillCam Express Delivery Device

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    SATP

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  • 모델명 / 제조번호(시리얼번호)
    FGS# 0366, Lot number: 14081, 13688, 14097, 14144, 13783 and 13504, UPC: 7290101362050 and FGS# 0367, Lot number: 13438, 13690, 13781, 13806, 14082, 14095, 14099.14145, 14249, 14370, 14568, 14508 and 14787, UPC: 7290101362067.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    U.S. Nationwide, Canada, Germany Israel and Australia.
  • 제품 설명
    Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    PillCam Express Delivery Device (Indicated for the transendoscopic delivery of the PillCam SB video capsule in patients who are unable to ingest the PillCam capsule or are known to have slow gastric emptying time)Part Numbers: FGS-0366 & FGS-0367Batch Numbers: 15720 to 18568Supplied between August 2010 and July 2012ARTG Number: 174813
  • Manufacturer