Device Recall Ultraxx

  • Modèle / numéro de série
    Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017
  • Classification du dispositif
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
  • Description du dispositif
    UltraxxTM Nephrostomy Balloon Set || The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Société-mère du fabricant (2017)
  • Source
    USFDA