BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spectral Color Overlay

    DI: 00195278630384 · Model: 1.0 · GE MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Spectral Color Overlay
    Primary DI
    00195278630384
    Version / Model
    1.0
    Catalog Number
    5929649
    Company Name
    GE MEDICAL SYSTEMS, INC.
    Labeler DUNS
    809785715
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-25
    Public Version
    1
    Public Version Date
    2023-09-04
    Public Version Status
    New
    Public Device Record Key
    0022bab6-2fe4-4ed6-bbee-dfffaaabf3d1

    Device Description

    Spectral Color Overlay MD Application Container for Smart Subscription

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JAK System, x-ray, tomography, computed

    GMDN Terms

    Code Name
    40867 CT system application software

    Identifiers

    Type ID
    Primary 00195278630384