BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RAYSCAN α-Expert3D

    DI: 08800003000197 · Model: M3DS-CT,Pano+One Shot Ceph(PaxScan 2530C) · Ray Co., Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RAYSCAN α-Expert3D
    Primary DI
    08800003000197
    Version / Model
    M3DS-CT,Pano+One Shot Ceph(PaxScan 2530C)
    Company Name
    Ray Co., Ltd
    Labeler DUNS
    690324087
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-15
    Public Version
    2
    Public Version Date
    2023-04-12
    Public Version Status
    Update
    Public Device Record Key
    87ba8373-9a1a-4d0b-b64e-b7123758885f

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    OAS X-Ray, Tomography, Computed, Dental

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 08800003000197

    Premarket Submissions

    Submission Number Supplement Number
    K190812 000