BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Gemini 810+980 Diode Laser Kit, International

    DI: 00861407000389 · Model: 8990 · AZENA MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gemini 810+980 Diode Laser Kit, International
    Primary DI
    00861407000389
    Version / Model
    8990
    Company Name
    AZENA MEDICAL, LLC
    Labeler DUNS
    073483242
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-22
    Public Version
    1
    Public Version Date
    2021-07-30
    Public Version Status
    New
    Public Device Record Key
    b4319f84-e644-4782-8688-52108d0d26cb
    Distribution End Date
    2021-07-22

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Dry Heat Sterilization

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument
    ILY Lamp, Infrared, Therapeutic Heating

    GMDN Terms

    Code Name
    60340 Dental diode laser system

    Identifiers

    Type ID
    Primary 00861407000389

    Premarket Submissions

    Submission Number Supplement Number
    K192617 000