PillCam Express Delivery Device

  • Modèle / numéro de série
    FGS-0366 and FGS-0377 | FGS-0366: 14081, 13688, 14097,14144, 13783, 13504FGS-0367: 13438, 13690, 137,81, 138,06, 14082, 14095, 14099,14145, 14249, 14370, 14568, 14508, 14787
  • Description du dispositif
    MD: Express Delivery Device
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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

3 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Nationwide, Canada, Germany Israel and Australia.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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