Devices

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

  • Modelo / Serial
    All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
  • Manufacturer
    Sandhill Scientific, Inc
  • 1 Event

Fabricante

Sandhill Scientific, Inc
  • Dirección del fabricante
    Sandhill Scientific, Inc, 9150 Commerce Center Cir Ste 500, Highlands Ranch CO 80129-1563
  • Source
    USFDA