BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CS 8200 3D Access

    DI: 60192155944864 · Model: 5944863 · CARESTREAM DENTAL LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CS 8200 3D Access
    Primary DI
    60192155944864
    Version / Model
    5944863
    Catalog Number
    5944863
    Company Name
    CARESTREAM DENTAL LLC
    Labeler DUNS
    019796106
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-12
    Public Version
    1
    Public Version Date
    2023-12-20
    Public Version Status
    New
    Public Device Record Key
    dc87d80f-b0bc-4db2-8c53-36c17ffca1bc

    Device Description

    CS 8200 3D ACCESS

    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
    OAS X-Ray, Tomography, Computed, Dental

    GMDN Terms

    Code Name
    61019 Cone beam computed tomography system, head/neck

    Identifiers

    Type ID
    Primary 60192155944864