BIOPLANT

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 216112 (Lot serial: All Lots); Model Catalog: 216114 (Lot serial: All Lots); Model Catalog: 216110 (Lot serial: All Lots); Model Catalog: 216112B (Lot serial: All Lots); Model Catalog: 216132 (Lot serial: All Lots)
  • 제품 설명
    BIOPLANT
  • Manufacturer
  • 1 Event

제조사

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model: Part Numbers 216110 (0.125g), 216112, (0.25g), 216114 (0.50g), 216132 (2x0.25g), Affected: All lots with expiration dates up to and including Oct-2017
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model: Part number 216112B, Affected: All lots with expiration date up to and including Oct-2017
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 216112 (Lot serial: 216132 - H005876 (12 syringes)); Model Catalog: 216132 (Lot serial: 216112 - 2685295 (18 syringes)); Model Catalog: 216112 (Lot serial: 216132 - 2685297 (4 syringes)); Model Catalog: 216132 (Lot serial: 216132 - 2685297 (4 syringes)); Model Catalog: 216112 (Lot serial: 216132 - 2649171 (4 syringes)); Model Catalog: 216132 (Lot serial: 216132 - 2649171 (4 syringes)); Model Catalog: 216132 (Lot serial: 216112 - 2720970 (6 syringes)); Model Catalog: 216132 (Lot serial: 216132 - H005876 (12 syringes)); Model Catalog: 216112 (Lot serial: 216132 - 2746762 (4 syringes)); Model Catalog: 216132 (Lot serial: 216132 - 2746762 (4 syringes)); Model Catalog: 216112 (Lot serial: 216132 - 2720971 (4 syringes)); Model Catalog: 216132 (Lot serial: 216132 - 2720971 (4 syringes)); Model Catalog: 216112 (Lot serial: 216112 - 2763764 (18 syringes)); Model Catalog: 216132 (Lot serial: 216112 - 2763764 (18 syringes)); Model Catalog: 216112 (Lot serial: 216112 - 2763763 (6 syringes)); Model Catalog
  • 제품 설명
    Bioplast
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    The BioPlant part numbers and lot numbers affected by this recall are as follows:  Product Description Part Numbers Lot Numbers  BioPlant Curved Syringe, 0.125g 216110 All Production  BioPlant Curved Syringe, 0.25g 216112  BioPlant Curved Svrinoe, 0.50<1 216114 Lots Within Shelf-Life  BioPlant Curved Svrinoe, 0.250 216132 20k  BioPlant Intro Pack 216112S
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
  • 제품 설명
    BioPlant, a dental bone grafting material. BioPlant || has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the || FDA and is classified as a Class II Medical Device. || BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. || BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    BioPlant Curved Syringe, multiple doses, BioPlant Intro Pack (synthetic dental bone grafts)BioPlant Curved Syringe 0.125gPart Number: 216110BioPlant Curved Syringe 0.25gPart Number: 216112BioPlant Curved Syringe 0.50gPart Number: 216114BioPlant Curved Syringe 0.25g (2 pack)Part Number; 216132BioPlant Intro PackPart Number: 216112B(Synthetic dental bone grafts)All production lots within shelf lifeARTG Number: 121686
  • Manufacturer