Devices

Device Recall Surgicutt Bleeding Time Device

  • Modelo / Serial
    Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including Arizona andTexas. .
  • Descripción del producto
    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. || The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.
  • Manufacturer
    ITC-Nexus Dx
  • 1 Event

Fabricante

ITC-Nexus Dx
  • Dirección del fabricante
    ITC-Nexus Dx, 23 Nevsky St, Edison NJ 08820-2425
  • Empresa matriz del fabricante (2017)
    Samsung Electronics Co., Ltd.
  • Source
    USFDA