BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SHINING3D®

    DI: 06970163082707 · Model: Atip 3iWS · Shining 3D Tech Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SHINING3D®
    Primary DI
    06970163082707
    Version / Model
    Atip 3iWS
    Company Name
    Shining 3D Tech Co., Ltd.
    Labeler DUNS
    529835314
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-24
    Public Version
    1
    Public Version Date
    2024-08-01
    Public Version Status
    New
    Public Device Record Key
    8e29a56d-b111-4cf1-b973-7799e12f4871

    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    High-level Disinfectant, Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

    GMDN Terms

    Code Name
    38597 Dental milling system, CAD/CAM, chairside

    Identifiers

    Type ID
    Primary 06970163082707