BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    CoolPulse 90 Electrode with Hand Controls

    Reg #: 9617070 · FEI: 3002807134 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GYRUS MEDICAL LTD.
    Registration Number
    9617070
    FEI Number
    3002807134
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FORTRAN RD., ST. MELLONS
    City
    CARDIFF Wales
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K113545

    Owner / Operator

    Firm Name
    ATL Technology LLC
    Operator Number
    10045899
    Address
    1335 West 1650 North
    City
    Springville
    State
    UT
    Postal Code
    84663
    Country
    US

    US Agent

    Business Name
    ATL Technology
    Contact Name
    Lauren Cordova
    Address
    1335 West 1650 North
    City
    Springville
    State
    UT
    ZIP
    84663
    Country
    US
    Email
    [email protected]
    Phone
    801 8534035 ext. 235

    Products

    Device Name Product Code
    Arthroscope HRX
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    CoolPulse 90 Electrode with Hand Controls CoolPulse 90 Electrode without Hand Controls Large Diameter Suction (LDS) Electrode One Piece Epoch Electrode One Piece Small Diameter Suction Electrode One Piece S50 Plus Electrode Low Profile Suction (LPS) Electrode

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)