Device Recall ELECTROLASE HYFRECATOR(R) ELECTRODES SHARP

  • 모델명 / 제조번호(시리얼번호)
    Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
  • 제품 설명
    ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. || Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    ConMed Corporation, 525 French Road, Utica NY 13502
  • 제조사 모회사 (2017)
  • Source
    USFDA