BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    GUIDE WIRE INTRODUCER NEEDLE

    Reg #: 3010966701 · FEI: 3010966701 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CUSTOM TUBE MANUFACTURING LLC
    Registration Number
    3010966701
    FEI Number
    3010966701
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    38-4, Hyeonseok-ro 733beon-gil, Gwangjeok-myeon
    City
    Yangju-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K082580

    Owner / Operator

    Firm Name
    CUSTOM TUBE MANUFACTURING LLC
    Operator Number
    10046953
    Address
    38-4, Hyeonseok-ro 733beon-gil, Gwangjeok-myeon
    City
    Yangju-si
    State
    Gyeonggi
    Postal Code
    11413
    Country
    KR

    US Agent

    Business Name
    SPECTRA MEDICAL DEVICES, LLC
    Contact Name
    Kathy Dassler
    Address
    299 BALLARDVALE STREET, SUITE 1
    City
    Wilmington
    State
    MA
    ZIP
    01887
    Country
    US
    Email
    [email protected]
    Phone
    978 6570889 ext. 5224

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    GUIDE WIRE INTRODUCER NEEDLE SPECTRA GUIDE GLIDE II GUIDE WIRE INTRODUCER NEEDLE SPECTRA GUIDE GLIDE GUIDE WIRE INTRODUCER NEEDLE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)