BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cryolife1999 (SP) - BGST-12 12mm Spreader Tip

    Reg #: 1047843 · FEI: 1047843 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1047843
    FEI Number
    1047843
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2072 SOUTHPORT RD., HWY. 295
    City
    SPARTANBURG
    State
    SC
    ZIP
    29306
    Country
    US

    Regulatory Submissions

    PMA Number
    P010003

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Glue, Surgical, Arteries MUQ

    Proprietary Names

    Cryolife1999 (SP) - BGST-12 12mm Spreader Tip Cryolife1999 (SP) - BGST-16 16mm Spreader Tip Cryolife1999 (SP) - BGAT-SY Mixing Tip Cryolife1999 (SP) - BG3502 BioGlue 2 mL Artivion10572 (SP) - BG3510 BioGlue 10 mL Artivion10572 (SP) - BG3502 BioGlue 2 mL Cryolife1999 (SP) - BioGlue Surgical Adhesive Artivion10572 (SP) - BG3515 BioGlue 5 mL Artivion10572 (LN,SP) - BG3510 BioGlue Surgical Adhesive, 10mL Artivion10572 (LN,SP) - BG3515 BioGlue Surgical Adhesive, 5mL Artivion10572 (LN,SP) - BG3502 BioGlue Surgical Adhesive, 2mL

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)