Device Recall SwishPlus Implant

  • 모델명 / 제조번호(시리얼번호)
    Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
  • 제품 설명
    SwishPlus Implant || Intended for use in support for fixed bridgework.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Westlake Village CA 91362-3171
  • 제조사 모회사 (2017)
  • Source
    USFDA