BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dental Imaging Software

    DI: 60889971045072 · Model: Dental Imaging Software · CARESTREAM HEALTH, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dental Imaging Software
    Primary DI
    60889971045072
    Version / Model
    Dental Imaging Software
    Catalog Number
    1045079
    Company Name
    CARESTREAM HEALTH, INC.
    Labeler DUNS
    793169512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    4743c02c-a2ba-423e-96bb-a95d79b93d5e

    Device Description

    Dental Imaging software update only

    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
    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
    LLZ System, image processing, radiological

    GMDN Terms

    Code Name
    40876 General-purpose dental x-ray system application software

    Identifiers

    Type ID
    Primary 60889971045072