Lumindex 3 LED Transilluminator 71-18835

GUDID 00723896009048

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,

PRACTICON, INC.

ENT transilluminator

• Primary Device ID: 00723896009048
• NIH Device Record Key: b47ecec5-1dd5-4402-ba4c-a74994cd3d73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumindex 3 LED Transilluminator
• Version Model Number: 7118835
• Catalog Number: 71-18835
• Company DUNS: 119193803
• Company Name: PRACTICON, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00723896009048 [Primary]

FDA Product Code

• HJN: Transilluminator, Battery-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-20
• Device Publish Date: 2018-07-20

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