Spot-On 2 LED Headlight - Illuminate the oral cavity without blinding your - PRACTICON, INC.

Duns Number:119193803

Device Description: Illuminate the oral cavity without blinding your patient. Spring clip mount fits most eyew 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.

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More Product Details

Catalog Number

71-31112

Brand Name

Spot-On 2 LED Headlight

Version/Model Number

08264B

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

HPP

Product Code Name

Headlamp, Operating, Battery-Operated

Device Record Status

Public Device Record Key

309825d8-4ad6-4020-ac8a-3c78fc60cfb4

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 19, 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