BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Hyperblue plus

    DI: 08033945934347 · Model: PDMS00246 · QUANTA SYSTEM SPA
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hyperblue plus
    Primary DI
    08033945934347
    Version / Model
    PDMS00246
    Company Name
    QUANTA SYSTEM SPA
    Labeler DUNS
    436045833
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-18
    Public Version
    4
    Public Version Date
    2023-06-16
    Public Version Status
    Update
    Public Device Record Key
    83c5563e-480d-45e3-8a7b-f85a419dde5a
    Distribution End Date
    2023-06-15

    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
    PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
    ILY Lamp, Infrared, Therapeutic Heating
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    60341 General/multiple surgical diode laser system

    Identifiers

    Type ID
    Primary 08033945934347