BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lumindex 3 LED Transilluminator

    DI: 00723896009048 · Model: 7118835 · PRACTICON, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lumindex 3 LED Transilluminator
    Primary DI
    00723896009048
    Version / Model
    7118835
    Catalog Number
    71-18835
    Company Name
    PRACTICON, INC.
    Labeler DUNS
    119193803
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-20
    Public Version
    1
    Public Version Date
    2018-08-20
    Public Version Status
    New
    Public Device Record Key
    b47ecec5-1dd5-4402-ba4c-a74994cd3d73

    Device Description

    With its brilliant white LED, the Lumindex 3 LED Transilluminator is ideal for diagnosing tooth fractures, detecting carious lesions and calculus, and locating hard-to-see root canals. Simply press the single ON/OFF button once for a high-intensity 30,000 lux beam, or press it again for lower-intensity 15,000 lux output. A third press turns the unit off. Lumindex 3 features an automatic power compensation circuit for consistent, constant output during the life of the batteries, as well as a low battery LED indicator. And Lumindex 3 turns itself off automatically after five minutes to conserve batteries. Handpiece can be cleaned easily with disinfectant wipes. Light guide is autoclavable to 273°F. Specifications: Light source: High-power LED. Color temperature: 6,500K. Radiant intensity at 5mm: Low Mode: 15,000 lux. High Mode: 30,000 lux. Batteries: (2) 1.5V AAA alkaline. Battery life: 3 hours (high power mode). Dimensions: 187mm (7-3/8") L x 16mm (5/8") max. diameter. Package includes Lumindex 3 handpiece, standard 3mm light guide, two AAA alkaline batteries,

    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
    Yes
    Has Serial Number
    No
    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
    HJN Transilluminator, Battery-Powered

    GMDN Terms

    Code Name
    34174 ENT transilluminator

    Identifiers

    Type ID
    Primary 00723896009048