BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cerafix Dura Substitute

    Reg #: 3020659113 · FEI: 3020659113 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLY-MED, INC.
    Registration Number
    3020659113
    FEI Number
    3020659113
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    116 Leader Drive
    City
    Piedmont
    State
    SC
    ZIP
    29673
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172603

    Owner / Operator

    Firm Name
    Poly-Med, Inc.
    Operator Number
    10034488
    Address
    51 Technology Drive
    City
    Anderson
    State
    SC
    Postal Code
    29625
    Country
    US

    Products

    Device Name Product Code
    Dura Substitute GXQ

    Proprietary Names

    Cerafix Dura Substitute

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)