BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MC2 App

    DI: 00860008892744 · Model: APP · OXOS Medical, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MC2 App
    Primary DI
    00860008892744
    Version / Model
    APP
    Company Name
    OXOS Medical, Inc.
    Labeler DUNS
    080323883
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-01
    Public Version
    2
    Public Version Date
    2026-01-12
    Public Version Status
    Update
    Public Device Record Key
    21b78ec1-792b-4f1a-ba7e-db20ef307a40

    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
    Yes
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    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
    OWB Interventional Fluoroscopic X-Ray System
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
    IZL System, X-Ray, Mobile

    GMDN Terms

    Code Name
    37658 Hand-held basic diagnostic x-ray system, digital

    Identifiers

    Type ID
    Primary 00860008892744