BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dentrix Smart Image

    DI: 00864058000319 · Model: 1 · REALCLOUD IMAGING, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dentrix Smart Image
    Primary DI
    00864058000319
    Version / Model
    1
    Company Name
    REALCLOUD IMAGING, INC.
    Labeler DUNS
    079879515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-01
    Public Version
    1
    Public Version Date
    2019-02-01
    Public Version Status
    New
    Public Device Record Key
    6ed5b231-efef-444e-8581-fa6876b13cce

    Device Description

    Dental Medical Device Data Systems (MDDS)

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OUG Medical Device Data System

    GMDN Terms

    Code Name
    44087 Radiology information system application software

    Identifiers

    Type ID
    Primary 00864058000319