Device Recall 0.8MM Diamond Ball, 7.3CM

  • 모델명 / 제조번호(시리얼번호)
    All lots are included in recall
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
  • 제품 설명
    MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. || Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • 제조사 모회사 (2017)
  • Source
    USFDA