Device Recall NuOss XC Sinus

  • 모델명 / 제조번호(시리얼번호)
    Lot BMCXU11P1. BMCXU11H3  Lot BMCXU11P1, BMCXU12P1
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to state of: MA.
  • 제품 설명
    NuOss XC Sinus || Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) || Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) || Manufacturer:- Collagen Matrix, || Distributor:- ACE Surgical Supply Co, Inc, || Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Collagen Matrix Inc, 509 Commerce St, Franklin Lakes NJ 07417-1374
  • 제조사 모회사 (2017)
  • Source
    USFDA