Devices

Device Recall WilsonCook Endoscopic Clipping Device

  • Modèle / numéro de série
    Lot numbers: W2965637, W2976210, W2978497, W2983595, W2986018, W2987394, W2987969, W2990400, and W2998860.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    (USA) Nationwide Distribution including the states of: CA, HI, MA, ME, NC and NY.
  • Description du dispositif
    Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical || Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.
  • Manufacturer
    Cook Endoscopy
  • 1 Event

Fabricant

Cook Endoscopy
  • Adresse du fabricant
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA