BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DRX-Compass X-ray System

    DI: 60889978624768 · Model: DRX-Compass 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-Compass X-ray System
    Primary DI
    60889978624768
    Version / Model
    DRX-Compass X-ray System
    Catalog Number
    8624769
    Company Name
    CARESTREAM HEALTH, INC.
    Labeler DUNS
    793169512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-28
    Public Version
    1
    Public Version Date
    2023-07-06
    Public Version Status
    New
    Public Device Record Key
    5bcd3934-4949-460f-a64b-80571357535e

    Device Description

    XRAY OTC 80KW 400KHU AUTOTILT CF OSHPD

    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
    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
    KPR System, x-ray, stationary

    GMDN Terms

    Code Name
    37645 Stationary basic diagnostic x-ray system, digital

    Identifiers

    Type ID
    Primary 60889978624768

    Premarket Submissions

    Submission Number Supplement Number
    K201373 000