BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Owandy Radiology

    DI: 03760262650210 · Model: I-Max Touch 3D · OWANDY RADIOLOGY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Owandy Radiology
    Primary DI
    03760262650210
    Version / Model
    I-Max Touch 3D
    Company Name
    OWANDY RADIOLOGY
    Labeler DUNS
    265612235
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2023-06-12
    Public Version Status
    Update
    Public Device Record Key
    1076a6a4-5340-4e33-af56-00e62ed9f49b
    Distribution End Date
    2022-08-29

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MUH System,X-Ray,Extraoral Source,Digital

    GMDN Terms

    Code Name
    61019 Cone beam computed tomography system, head/neck

    Identifiers

    Type ID
    Primary 03760262650210