BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ajust Adjustable Single Incision

    Reg #: 3005636544 · FEI: 3005636544 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BARD SHANNON LIMITED
    Registration Number
    3005636544
    FEI Number
    3005636544
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SAN GERONIMO INDUSTRIAL PARK, Km. 76.7 Lot #1 Road #3 Bo. Rio Abajo
    City
    HUMACAO
    State
    PR
    ZIP
    00791
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092607

    Owner / Operator

    Firm Name
    C. R. Bard, Inc.
    Operator Number
    2212754
    Address
    1 Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    Products

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

    Proprietary Names

    Ajust Adjustable Single Incision

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)