Spot-On 2 LED Headlight 71-31112

GUDID 00723896008645

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.

PRACTICON, INC.

General-purpose light source

• Primary Device ID: 00723896008645
• NIH Device Record Key: 309825d8-4ad6-4020-ac8a-3c78fc60cfb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spot-On 2 LED Headlight
• Version Model Number: 08264B
• Catalog Number: 71-31112
• 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	00723896008645 [Primary]

FDA Product Code

• HPP: Headlamp, Operating, Battery-Operated

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: 2018-07-19

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