BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sirius MRI Marker

    Reg #: 3008236846 · FEI: 3008236846 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KEYSTONE MANUFACTURING
    Registration Number
    3008236846
    FEI Number
    3008236846
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6387 Technology Ave Ste B
    City
    Kalamazoo
    State
    MI
    ZIP
    49009
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131689

    Owner / Operator

    Firm Name
    Keystone Manufacturing, LLC
    Operator Number
    10031160
    Address
    6387 Technology Avenue, Suite B
    City
    Kalamazoo
    State
    MI
    Postal Code
    49009
    Country
    US

    Products

    Device Name Product Code
    Source, Brachytherapy, Radionuclide KXK

    Proprietary Names

    Sirius MRI Marker

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)