Device Recall AlgiNot

  • 모델명 / 제조번호(시리얼번호)
    ¿Product Part Numbers Lot Number  AlgiNot Intra Kit 34683 1-1017  AlgiNot Volume Refills 34682 1-1017
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.
  • 제품 설명
    The brand name of the device is AlgiNot, a dental impression material. || Product Part Numbers || AlgiNot Intra Kit 34683 || AlgiNot Volume Refills 34682 || Lot Number 1-1017 || AlgiNot is a Class II Medical Device. The device listing number this product is || 0136496 and the establishment registration number for Kerr Corporation is 1815757. || Intended as an alternative to traditional alginate materials.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Kerr Corporation, 28200 Wick Rd, Romulus MI 48174-2639
  • 제조사 모회사 (2017)
  • Source
    USFDA