BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GORE-TEX Soft Tissue Patch

    DI: 00733132600564 · Model: 1405010010 · 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-TEX Soft Tissue Patch
    Primary DI
    00733132600564
    Version / Model
    1405010010
    Catalog Number
    1405010010
    Company Name
    W. L. Gore & Associates, Inc.
    Labeler DUNS
    967358115
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-26
    Public Version
    10
    Public Version Date
    2023-12-25
    Public Version Status
    Update
    Public Device Record Key
    b3fc6d99-d84a-41d0-9d5c-84568fcd36dd

    Device Description

    GORE-TEX SOFT TISSUE PATCH 5.0cmX10.0cmX1.0mm

    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 00733132600564

    Customer Contacts

    Phone
    800-528-8763
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K963619 000

    Device Sizes

    Type Value Unit Text
    Height 1 Millimeter
    Length 10 Centimeter
    Width 5 Centimeter