BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gendex GXC-300™ intraoral camera

    DI: EKAV082243310 · Model: 0.822.4331 · GENDEX CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gendex GXC-300™ intraoral camera
    Primary DI
    EKAV082243310
    Version / Model
    0.822.4331
    Catalog Number
    GXC300
    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
    6
    Public Version Date
    2022-01-31
    Public Version Status
    Update
    Public Device Record Key
    b373d4bf-9daf-4897-95dd-0c13790d0340

    Device Description

    Digital intraoral camera

    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
    EIA UNIT, OPERATIVE DENTAL

    GMDN Terms

    Code Name
    58857 Multi-purpose digital medical camera

    Identifiers

    Type ID
    Primary EKAV082243310

    Customer Contacts

    Phone
    +18003238029
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K040691 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius