BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Standard Imaging TomoElectrometer

    DI: 00850019946222 · Model: 90016 · STANDARD IMAGING INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Standard Imaging TomoElectrometer
    Primary DI
    00850019946222
    Version / Model
    90016
    Catalog Number
    90016
    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
    907a1e63-e2d6-4e56-b751-b3309a80435a

    Device Description

    Standard Imaging TomoElectrometer is a 8-channel electrometer designed to be connected to a radiation detector, (ionization chamber, well chamber, or diode detector), and measure the electrical current produced by the detector during irradiation.

    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
    36596 Radiation electrometer

    Identifiers

    Type ID
    Primary 00850019946222