BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Omega Medical Imaging, LLC

    DI: 00853901007025 · Model: Soteria.AI · OMEGA MEDICAL IMAGING, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Omega Medical Imaging, LLC
    Primary DI
    00853901007025
    Version / Model
    Soteria.AI
    Company Name
    OMEGA MEDICAL IMAGING, LLC
    Labeler DUNS
    622534493
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-18
    Public Version
    1
    Public Version Date
    2022-01-26
    Public Version Status
    New
    Public Device Record Key
    47709914-c028-43fe-a043-e9b496d8a2cd

    Device Description

    Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and Image Processor.

    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
    No
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    GMDN Terms

    Code Name
    37623 Stationary angiographic x-ray system, digital

    Identifiers

    Type ID
    Primary 00853901007025