BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Varex Imaging

    DI: 08718755001068 · Model: 12835-10 · 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
    08718755001068
    Version / Model
    12835-10
    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
    2019-09-02
    Public Version
    2
    Public Version Date
    2021-03-18
    Public Version Status
    Update
    Public Device Record Key
    982bbb76-51ed-435a-a4d0-51d659268753

    Device Description

    The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-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
    IZO Generator, High-Voltage, X-Ray, Diagnostic

    GMDN Terms

    Code Name
    38336 Solid-state-semiconductor radiation measuring probe

    Identifiers

    Type ID
    Primary 08718755001068