BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GEM Flex

    Reg #: 3006369484 · FEI: 3006369484 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NEOCOIL, LLC
    Registration Number
    3006369484
    FEI Number
    3006369484
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    N27 W23910A PAUL RD.
    City
    Pewaukee
    State
    WI
    ZIP
    53072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113474

    Owner / Operator

    Firm Name
    NeoCoil, LLC
    Operator Number
    9099325
    Address
    N27 W23910A PAUL RD., Suite A
    City
    Pewaukee
    State
    WI
    Postal Code
    53072
    Country
    US

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    GEM Flex GEM Flex Coil 16-L Array, 1.5T Receive Only 1.5T GEM Flex Coil MetaFlex Coil GEM Flex Coil 16-M Array, 1.5T Receive Only GEM Flex Coil, 1.5T GEM Flex Coil 16-S Array, 1.5T Receive Only GEM Flex Interface 16ch Fixed, 1.5T P Connector GEM Flex Interface 16ch Fixed, 1.5T HD Connector

    Establishment Types

    Manufacture Medical Device