BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    GORE DrySeal Flex Introducer Sheath

    Reg #: 9616683 · FEI: 3004970277 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TELEFLEX MEDICAL
    Registration Number
    9616683
    FEI Number
    3004970277
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ANNACOTTY BUSINESS PARK
    City
    ANNACOTTY Limerick
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K160254

    Owner / Operator

    Firm Name
    Teleflex
    Operator Number
    9062981
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Divya Raman

    US Agent

    Business Name
    Teleflex, Inc.
    Contact Name
    Divya Raman
    Address
    3015 Carrington Mill Boulevard
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    612 4231738

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    GORE DrySeal Flex Introducer Sheath

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)