BEUDAMED
    FDA Registration Active 🇺🇸 United States

    durasis DURAL GRAFT

    Reg #: 1835959 · FEI: 3002340648 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    COOK BIOTECH, INC.
    Registration Number
    1835959
    FEI Number
    3002340648
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1425 INNOVATION PLACE
    City
    West Lafayette
    State
    IN
    ZIP
    47906
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160869

    Owner / Operator

    Firm Name
    COOK BIOTECH, INC.
    Operator Number
    9031415
    Address
    1425 INNOVATION PLACE, --
    City
    West Lafayette
    State
    IN
    Postal Code
    47906
    Country
    US
    Correspondent
    Monica A Bravo

    Products

    Device Name Product Code
    Mesh, Surgical FTM
    Dura Substitute GXQ

    Proprietary Names

    durasis DURAL GRAFT Biodesign Dural Graft Biodesign Peyronie's Repair Graft Biodesign Tissue Graft Biodesign 1-Layer Tissue Graft Biodesign 4-Layer Tissue Graft

    Establishment Types

    Manufacture Medical Device