Device Recall Replacement balloons for use with Sandhill Anorectal Manometry Probes.

  • 모델명 / 제조번호(시리얼번호)
    All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed nationwide including PR. Military distibution in MD and TX. Veteran Affairs facilities located in AR, CO, CT, HI, and NC. Foreign distribution includesTaiwan, Saudi Arabia, England, Malaysia, Korea, Chile, Venequela, China, and Brazil.
  • 제품 설명
    Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Sandhill Scientific, Inc, 9150 Commerce Center Cir Ste 500, Highlands Ranch CO 80129-1563
  • Source
    USFDA