BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    EchoTip Ultra Endobronchial High Definition Ultrasound Needle

    Reg #: 3001845648 · FEI: 3001845648 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COOK IRELAND LTD
    Registration Number
    3001845648
    FEI Number
    3001845648
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    O HALLORAN ROAD, NATIONAL TECHNOLOGY PARK
    City
    LIMERICK
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K210476

    Owner / Operator

    Firm Name
    COOK IRELAND LTD
    Operator Number
    9052427
    Address
    O'HALLORAN ROAD, NATIONAL TECHNOLOGY PARK
    City
    LIMERICK
    State
    IE-LK
    Postal Code
    00000
    Country
    IE
    Correspondent
    Sinead Egan

    US Agent

    Business Name
    Cook Medical Holdings LLC
    Contact Name
    Matt Graf
    Address
    750 Daniels Way
    City
    Bloomington
    State
    IN
    ZIP
    47404
    Country
    US
    Email
    [email protected]
    Phone
    812 3392235

    Products

    Device Name Product Code
    Biopsy Needle FCG

    Proprietary Names

    EchoTip Ultra Endobronchial High Definition Ultrasound Needle EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Pentax Scopes EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Olypmus Scopes EchoTip Ultra Endoscopic Ultrasound Needle EchoTip Procore HD Ultrasound Biopsy Needle

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device