Lumindex 3 LED Transilluminator Standard 3mm Light Guide

Basic Information

• Brand Name: Lumindex 3 LED Transilluminator Standard 3mm Light Guide
• Primary DI: 00723896009079
• Version / Model: 7118836
• Catalog Number: 71-18836
• Company Name: PRACTICON, INC.
• Labeler DUNS: 119193803
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-20
• Public Version: 1
• Public Version Date: 2018-08-20
• Public Version Status: New
• Public Device Record Key: 85da3f9c-e8fe-4682-8a76-44ef02713d56

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HJN	Transilluminator, Battery-Powered	Ophthalmic	886.1945	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00723896009079	GS1