Lumindex 3 LED Transilluminator - With its brilliant white LED, the Lumindex 3 LED - PRACTICON, INC.

Duns Number:119193803

Device Description: With its brilliant white LED, the Lumindex 3 LED Transilluminator is ideal for diagnosing 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,

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More Product Details

Catalog Number

71-18835

Brand Name

Lumindex 3 LED Transilluminator

Version/Model Number

7118835

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HJN

Product Code Name

Transilluminator, Battery-Powered

Device Record Status

Public Device Record Key

b47ecec5-1dd5-4402-ba4c-a74994cd3d73

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRACTICON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 93
2 A medical device with a moderate to high risk that requires special controls. 2