Device Recall Urethral Warmer System

  • Modelo / Serial
    GW469, GW470, GW468, GW472
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, including CA, GA, TX and the country of Canada.
  • Descripción del producto
    Urethral Warmer System Model number FPRCH3001 || The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Galil Medical, 4364 Round Lake Road, Arden Hills MN 55112
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA