BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Avaulta Plus Biosynthetic Support

    Reg #: 3005636544 · FEI: 3005636544 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    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
    K063712

    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, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed PAI
    Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed OTP

    Proprietary Names

    Avaulta Plus Biosynthetic Support Avualta Solo Synthetic Support

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)