Device Recall Ultraxx

  • 모델명 / 제조번호(시리얼번호)
    Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • 제조사 모회사 (2017)
  • Source
    USFDA