BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Owandy Radiology

    DI: 03760262652337 · Model: Owandy-CR · 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
    03760262652337
    Version / Model
    Owandy-CR
    Catalog Number
    9458900021
    Company Name
    OWANDY RADIOLOGY
    Labeler DUNS
    265612235
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-20
    Public Version
    2
    Public Version Date
    2023-06-12
    Public Version Status
    Update
    Public Device Record Key
    9390ac77-a4cb-4e4e-b8ce-4b5e209a42f2

    Device Description

    Owandy-CR V2 USB

    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
    45256 Digital imaging cassette/storage phosphor screen, dental

    Identifiers

    Type ID
    Primary 03760262652337

    Premarket Submissions

    Submission Number Supplement Number
    K133271 000
    K143703 000