BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    GORE DRYSEAL FLEX INTRODUCER SHEATH

    Reg #: 3015138222 · FEI: 3015138222 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Gore European Warehouse Support
    Registration Number
    3015138222
    FEI Number
    3015138222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Doctor Paul Janssenweg 150
    City
    Tilburg Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K160254

    Owner / Operator

    Firm Name
    W. L. GORE & ASSOCIATES, INC.
    Operator Number
    9925013
    Address
    1505 North Fourth Street
    City
    Flagstaff
    State
    AZ
    Postal Code
    86004
    Country
    US
    Correspondent
    Lisa Wells

    US Agent

    Business Name
    W. L. GORE & ASSOCIATES, INC.
    Contact Name
    Lisa Wells
    Address
    1505 N Fourth St.
    City
    Flagstaff
    State
    AZ
    ZIP
    86004
    Country
    US
    Email
    [email protected]
    Phone
    928 8644219

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    GORE DRYSEAL FLEX INTRODUCER SHEATH

    Establishment Types

    Manufacture Medical Device