BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    T-SLING

    DI: 28032919892120 · Model: 5194001400 · HERNIAMESH SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    T-SLING
    Primary DI
    28032919892120
    Version / Model
    5194001400
    Company Name
    HERNIAMESH SRL
    Labeler DUNS
    459310140
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-08-05
    Public Version
    7
    Public Version Date
    2023-07-20
    Public Version Status
    Update
    Public Device Record Key
    b2c7c6f7-2e15-4e7c-b66b-32c730b84b4c
    Distribution End Date
    2016-12-31

    Device Description

    The code 5194001400, brand name “T-Sling” where T stands for tension-free, is a medical device entirely made in Polypropylene monofilament used for the treatment of stress urinary incontinence (SUI).

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 28032919892120
    Unit of Use 18032919892123