BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    GYNECARE TVT™ with Abdominal Guides System

    Reg #: 3003702646 · FEI: 3003702646 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ETHICON SARL
    Registration Number
    3003702646
    FEI Number
    3003702646
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PUITS GODET 20
    City
    NEUCHATEL
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K201686

    Owner / Operator

    Firm Name
    ETHICON INC.
    Operator Number
    2210968
    Address
    1000 US Highway 202 S.
    City
    Raritan
    State
    NJ
    Postal Code
    08869
    Country
    US
    Correspondent
    Reynaldo Librojo

    US Agent

    Business Name
    ETHICON Inc
    Contact Name
    Reynaldo Librojo
    Address
    1000 Us Highway 202
    City
    Raritan
    State
    NJ
    ZIP
    08869
    Country
    US
    Email
    [email protected]
    Phone
    908 8086028

    Products

    Device Name Product Code
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence PWJ

    Proprietary Names

    GYNECARE TVT™ with Abdominal Guides System GYNECARE TVT™ Introducer and Catheter Guide GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide GYNECARE TVT™ System GYNECARE TVT™ Obturator System and Passers and Winged Guide GYNECARE TVT EXACT™ Continence System and Trocar

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)