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    FDA UDI In Commercial Distribution 🇺🇸 United States

    DRX-Revolution Mobile X-ray System

    DI: 60889975950013 · Model: DRX-Revolution Mobile X-ray System · CARESTREAM HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DRX-Revolution Mobile X-ray System
    Primary DI
    60889975950013
    Version / Model
    DRX-Revolution Mobile X-ray System
    Catalog Number
    AF5684
    Company Name
    CARESTREAM HEALTH, INC.
    Labeler DUNS
    793169512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-31
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    da081f1f-ecbf-4d3f-b83e-a0abce7faf82

    Device Description

    MOBILE X-RAY GENERATOR

    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
    Yes
    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
    IZO Generator, high-voltage, x-ray, diagnostic

    GMDN Terms

    Code Name
    37605 Diagnostic x-ray system generator, mobile

    Identifiers

    Type ID
    Primary 60889975950013