BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    GORE DUALMESH PLUS BIOMATERIAL

    DI: 00733132601097 · Model: 1DLMCP02 · W. L. Gore & Associates, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GORE DUALMESH PLUS BIOMATERIAL
    Primary DI
    00733132601097
    Version / Model
    1DLMCP02
    Catalog Number
    1DLMCP02
    Company Name
    W. L. Gore & Associates, Inc.
    Labeler DUNS
    967358115
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-07
    Public Version
    7
    Public Version Date
    2023-09-04
    Public Version Status
    Update
    Public Device Record Key
    f9cac783-2a2c-4a3d-bf89-8ceb1bae73b2
    Distribution End Date
    2023-09-01

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FTL Mesh, Surgical, Polymeric

    GMDN Terms

    Code Name
    60300 Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

    Identifiers

    Type ID
    Primary 00733132601097

    Customer Contacts

    Phone
    8005288763
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K063435 000

    Device Sizes

    Type Value Unit Text
    Length 12 Centimeter
    Width 8 Centimeter
    Height 1 Millimeter