BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GammaTile

    Reg #: 3014663932 · FEI: 3014663932 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GT MEDICAL TECHNOLOGIES, INC
    Registration Number
    3014663932
    FEI Number
    3014663932
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1809 S Holbrook Ln, STE 107
    City
    Tempe
    State
    AZ
    ZIP
    85281
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190296

    Owner / Operator

    Firm Name
    GT Medical Technologies, Inc
    Operator Number
    10058091
    Address
    1809 S Holbrook Ln., Tempe, AZ,, STE 107
    City
    Tempe
    State
    AZ
    Postal Code
    85281
    Country
    US
    Correspondent
    Jessica Newhard

    Products

    Device Name Product Code
    Source, Brachytherapy, Radionuclide KXK

    Proprietary Names

    GammaTile

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198