BEUDAMED
    FDA Registration Active 🇺🇸 United States

    eTRAX Needle System

    Reg #: 3034286426 · FEI: 3034286426 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CIVCO Medical Instruments Co., Inc.
    Registration Number
    3034286426
    FEI Number
    3034286426
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    750 Lois Lane
    City
    Coralville
    State
    IA
    ZIP
    52241
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092619

    Owner / Operator

    Firm Name
    CIVCO Medical Instruments Co., Inc.
    Operator Number
    1937223
    Address
    750 Lois Lane, --
    City
    Coralville
    State
    IA
    Postal Code
    52241
    Country
    US
    Correspondent
    JIM - LEONG

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    eTRAX Needle System Active Fiducial Marker ViruTRAX Instrument Navigator General Purpose Sensor eTRAX Variable Angle Needle Guide EMT System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device