BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    GORE MYCROMESH PLUS Biomaterial

    DI: 00733132601707 · Model: 1MYMP16 · 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 MYCROMESH PLUS Biomaterial
    Primary DI
    00733132601707
    Version / Model
    1MYMP16
    Catalog Number
    1MYMP16
    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
    4
    Public Version Date
    2020-10-21
    Public Version Status
    Update
    Public Device Record Key
    1a938335-e8bc-488f-bbad-2a07898f057f
    Distribution End Date
    2018-01-15

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    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
    61423 Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial

    Identifiers

    Type ID
    Primary 00733132601707

    Customer Contacts

    Phone
    8005288763
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K063435 000

    Device Sizes

    Type Value Unit Text
    Width 20 Centimeter
    Length 30 Centimeter
    Height 1 Millimeter