Device Recall Spirit MB Bracket

  • 모델명 / 제조번호(시리얼번호)
    Part Number 494-0110, Lot Number 081351013.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Internationally Distributed in the country of Japan.
  • 제품 설명
    Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. || Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot #02112284
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.
  • 제품 설명
    Spirit MB Brackets, part #494-1210. || The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot #111069607, 031144457
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.
  • 제품 설명
    Spirit MB Brackets, part #494-1211. || The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
  • Manufacturer