AccessGUDID - DEVICE: Lumindex 3 LED Transilluminator (00723896009048)

GUDID

Device Identifier (DI) Information

Brand Name: Lumindex 3 LED Transilluminator
Version or Model: 7118835
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-18835
Company Name: PRACTICON, INC.

Primary DI Number: 00723896009048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: 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,

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34174	ENT transilluminator	A hand-held instrument intended to be used to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination. It is connected through a light cable, that may or may not be part of the device, to a light source that generates the light. Its exterior is typically made of high-grade stainless steel; it has a fibreoptic bundle core that conducts the light to the target site. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJN	Transilluminator, Battery-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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