BEUDAMED
    FDA Registration Active 🇺🇸 United States

    THERAGENICS CORP.

    Reg #: 1037598 · FEI: 1037598 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    THERAGENICS CORP.
    Registration Number
    1037598
    FEI Number
    1037598
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5203 BRISTOL INDUSTRIAL WAY
    City
    BUFORD
    State
    GA
    ZIP
    30518
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071550

    Owner / Operator

    Firm Name
    Theragenics Corporation
    Operator Number
    1037598
    Address
    5203 BRISTOL INDUSTRIAL WAY, --
    City
    Buford
    State
    GA
    Postal Code
    30518
    Country
    US
    Correspondent
    Kenneth Gaitor

    Products

    Device Name Product Code
    Source, Brachytherapy, Radionuclide KXK
    System, Applicator, Radionuclide, Manual IWJ
    Wax, Bone MTJ

    Proprietary Names

    Fiducial Marker Needles Seed Implant Needle Set THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 TheraStrand OSCERA 7 Manual IsoLoader 2 (MIL 2) Manual IsoLoader AnchorMarker Localization Needle (Anchorseed) TheraLoad/ Custom Loaded Needles 910 Seeding Spacers I-SEED (AgX100)

    Establishment Types

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