BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spot-On 2 LED Headlight

    DI: 00723896008645 · Model: 08264B · PRACTICON, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Spot-On 2 LED Headlight
    Primary DI
    00723896008645
    Version / Model
    08264B
    Catalog Number
    71-31112
    Company Name
    PRACTICON, INC.
    Labeler DUNS
    119193803
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-19
    Public Version
    1
    Public Version Date
    2018-08-20
    Public Version Status
    New
    Public Device Record Key
    309825d8-4ad6-4020-ac8a-3c78fc60cfb4

    Device Description

    Illuminate the oral cavity without blinding your patient. Spring clip mount fits most eyewear. Loupe mount also included. Continuously adjustable spot size, from 0.6" dia. to 3" dia. at a working distance of 14". XY-adjustable light mount directs illumination exactly where you need it. Eight brightness levels to suit varying lighting needs. Long-lasting LED bulb provides crisp, white light. Sharp, circular focus eliminates perimeter "halos." Weighs only 0.8 oz. (without cord or battery). Specifications: Operating time: 2-1/2 hours on one six-hour charge. Spot diameter: 0.6"-3" at 14" working distance. Lamp weight: 0.8 oz. (without cord or battery). Light intensity: adjustable up to 23,000 lux. Color temp.: 6,000K (±1,000). Battery: 2,600mAh rechargeable Lithium. System includes 5V charger, spring clip mount, loupe mount, two battery packs, clip-on leather battery case, cord clips, and padded storage case. One year warranty.

    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
    HPP Headlamp, Operating, Battery-Operated

    GMDN Terms

    Code Name
    32037 General-purpose light source

    Identifiers

    Type ID
    Primary 00723896008645