BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gendex GXS-700™ intraoral sensor

    DI: EKAV101076560 · Model: 1.010.7656 · GENDEX CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gendex GXS-700™ intraoral sensor
    Primary DI
    EKAV101076560
    Version / Model
    1.010.7656
    Catalog Number
    10107656
    Company Name
    GENDEX CORP.
    Labeler DUNS
    144575763
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2022-01-31
    Public Version Status
    Update
    Public Device Record Key
    739701b6-6cb7-4c95-98e4-6b7ccac0f012

    Device Description

    Size 1, Size 2

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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 EKAV101076560

    Customer Contacts

    Phone
    +18003238029
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K090458 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    5 – 30 Degrees Celsius