BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORT200

    DI: 00857534006738 · Model: 113821-000 · IMRIS Imaging, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ORT200
    Primary DI
    00857534006738
    Version / Model
    113821-000
    Company Name
    IMRIS Imaging, Inc.
    Labeler DUNS
    079990922
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-04
    Public Version
    2
    Public Version Date
    2025-04-08
    Public Version Status
    Update
    Public Device Record Key
    90837a2b-bdbc-45c2-89e8-8607825227bb

    Device Description

    ORT200 Covered Table Assembly V2

    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
    MR Conditional
    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
    FQO Table, Operating-Room, Ac-Powered
    KXJ Table, Radiologic

    GMDN Terms

    Code Name
    40655 Basic diagnostic x-ray system table, powered

    Identifiers

    Type ID
    Primary 00857534006738