BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    ECHELON ENDOPATH Staple Line Reinforcement

    Reg #: 3014272734 · FEI: 3014272734 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GMED Healthcare BVBA ( a Johnson & Johnson Company)
    Registration Number
    3014272734
    FEI Number
    3014272734
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    European Distribution Centre, Rue du Luxembourg 5
    City
    Courcelles Luxembourg
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K190937

    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, Absorbable, Staple Line Reinforcement OXC

    Proprietary Names

    ECHELON ENDOPATH Staple Line Reinforcement

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device