BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Artemis-TPOS

    DI: 00860009734821 · Model: 1.0 · Eigen Health Services LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Artemis-TPOS
    Primary DI
    00860009734821
    Version / Model
    1.0
    Catalog Number
    900-20000-02
    Company Name
    Eigen Health Services LLC
    Labeler DUNS
    117062155
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-28
    Public Version
    1
    Public Version Date
    2026-02-05
    Public Version Status
    New
    Public Device Record Key
    dbc02ccb-1bb9-4c2c-b3af-02aa822e5669

    Device Description

    3D workstation for transperineal only biopsy navigation and planning of the prostate.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEH Unit, Cryosurgical, Accessories
    QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

    GMDN Terms

    Code Name
    60656 Rectal ultrasound navigational image processor

    Identifiers

    Type ID
    Primary 00860009734821