Device Recall Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit

  • 모델명 / 제조번호(시리얼번호)
    NL950-V - Lot Numbers: 30500R130474 (exp. 8/31/2011); 30500R134098 (exp. 10/31/2011); 30500R139222 (exp. 11/30/2011); 30500R143588 (exp. 1/31/2012); 30500R146383 (exp. 1/31/2012); 30500R147342 (exp. 2/29/2012); and 30500R147899 (exp. 2/29/2012) and  NL950-VC - Lot Numbers: 138999 (exp. 9/30/2011); and 142754 (exp. 12/31/2011).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US (states of AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, and VA), Belgium and Malaysia.
  • 제품 설명
    Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC. || This intracranial pressure (ICP) catheter is indicated for use on patients that require continuous invasive intracranial pressure monitoring and/or cerebrospinal drainage. Access is achieved through a tunneled technique using the included trocar.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Integra Neuro Sciences, 5955 Pacific Center Blvd, San Diego CA 92121
  • Source
    USFDA