Belos VRT

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 78140141, 78140145, 78140146, 78140147, 78140148, 78140150, 78140151, 78140152.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The firm distributes to physicians located throughout the US.
  • 제품 설명
    Belos VR-T Implantable Cardioverter Defibrillator
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biotronik Inc, 6024 Jean Road, Lake Oswego OR 97035-5369
  • 제조사 의견
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 7814xxxx
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The firm distributes to physicians located throughout the US.
  • 제품 설명
    Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.
  • Manufacturer