BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Standard Imaging Exradin A11TW Ion Chamber

    DI: 00850019946208 · Model: 92708 · STANDARD IMAGING INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Standard Imaging Exradin A11TW Ion Chamber
    Primary DI
    00850019946208
    Version / Model
    92708
    Catalog Number
    92708
    Company Name
    STANDARD IMAGING INC.
    Labeler DUNS
    788084705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-22
    Public Version
    1
    Public Version Date
    2023-06-30
    Public Version Status
    New
    Public Device Record Key
    49ee4e9c-4a65-45c9-82d1-c63efcb6f209

    Device Description

    Standard Imaging Exradin A11TW is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).

    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
    LHO Instrument, Quality-Assurance, Radiologic

    GMDN Terms

    Code Name
    38323 Radiation condenser R-meter

    Identifiers

    Type ID
    Primary 00850019946208