BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KaVo GXS-700™ intraoral sensor

    DI: EKAV101305120 · Model: 1.013.0512 · GENDEX CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    KaVo GXS-700™ intraoral sensor
    Primary DI
    EKAV101305120
    Version / Model
    1.013.0512
    Company Name
    GENDEX CORP.
    Labeler DUNS
    144575763
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-21
    Public Version
    1
    Public Version Date
    2022-01-31
    Public Version Status
    New
    Public Device Record Key
    17e7e01b-5c83-4887-85e2-4ca7a2ab1390

    Device Description

    Size 1 Kit

    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
    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

    GMDN Terms

    Code Name
    44905 Dental digital imaging sensor, intraoral

    Identifiers

    Type ID
    Primary EKAV101305120

    Premarket Submissions

    Submission Number Supplement Number
    K090458 000