BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Varex Imaging

    DI: 08718755001464 · Model: 19386-03 · Varex Imaging Nederland B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Varex Imaging
    Primary DI
    08718755001464
    Version / Model
    19386-03
    Company Name
    Varex Imaging Nederland B.V.
    Labeler DUNS
    413223942
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-24
    Public Version
    2
    Public Version Date
    2021-03-18
    Public Version Status
    Update
    Public Device Record Key
    29094ed3-9510-431c-918f-86aa73896213

    Device Description

    The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics as an accessory of an X-ray system in a professional healthcare facility environment and is intended to be holding image receptor. The device is one out of the Harmony 3-series.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IXY Holder, Radiographic Cassette, Wall-Mounted

    GMDN Terms

    Code Name
    14473 X-ray film cassette holder

    Identifiers

    Type ID
    Primary 08718755001464