BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Durepair Dura Regeneration Matrix

    Reg #: 3004170064 · FEI: 3004170064 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TEI BIOSCIENCES INC.
    Registration Number
    3004170064
    FEI Number
    3004170064
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 ELKINS ST
    City
    BOSTON
    State
    MA
    ZIP
    02127
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161370

    Owner / Operator

    Firm Name
    Integra LifeSciences Corporation
    Operator Number
    9004007
    Address
    1100 Campus Rd
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US

    Products

    Device Name Product Code
    Dura Substitute GXQ

    Proprietary Names

    Durepair Dura Regeneration Matrix

    Establishment Types

    Manufacture Medical Device