BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Owandy Radiology

    DI: 03760262651811 · Model: I-Max 3D · OWANDY RADIOLOGY
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Owandy Radiology
    Primary DI
    03760262651811
    Version / Model
    I-Max 3D
    Catalog Number
    9304100011
    Company Name
    OWANDY RADIOLOGY
    Labeler DUNS
    265612235
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-22
    Public Version
    3
    Public Version Date
    2023-06-12
    Public Version Status
    Update
    Public Device Record Key
    d1797339-e761-49e6-8f90-04df980904ac

    Device Description

    I-MAX 3D PAN ONLY 110-120V

    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
    OAS X-Ray, Tomography, Computed, Dental
    MUH System, X-Ray, Extraoral Source, Digital

    GMDN Terms

    Code Name
    44245 Stationary panoramic/tomographic dental x-ray system, digital

    Identifiers

    Type ID
    Primary 03760262651811