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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gendex CB-500™ HD imaging system

    DI: EKAV083030000 · Model: 0.830.3000 · Dental Imaging Technologies Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gendex CB-500™ HD imaging system
    Primary DI
    EKAV083030000
    Version / Model
    0.830.3000
    Catalog Number
    08303000
    Company Name
    Dental Imaging Technologies Corporation
    Labeler DUNS
    800111106
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    6
    Public Version Date
    2022-08-30
    Public Version Status
    Update
    Public Device Record Key
    4cf2e94a-cba7-499e-b34c-b489afa20c25

    Device Description

    Dental CBCT

    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
    Yes
    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

    GMDN Terms

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

    Identifiers

    Type ID
    Primary EKAV083030000

    Customer Contacts

    Phone
    +18003238029
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K061284 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    10 – 35 Degrees Celsius