BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Align Urethral Support System

    Reg #: 1018233 · FEI: 1018233 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    C.R. BARD, INC.
    Registration Number
    1018233
    FEI Number
    1018233
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8195 INDUSTRIAL BLVD.
    City
    COVINGTON
    State
    GA
    ZIP
    30014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070073

    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, Retropubic Or Transobturator OTN

    Proprietary Names

    Align Urethral Support System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Sterilize Medical Device for Another Party (Contract Sterilizer)