Retitrack

Basic Information

• Brand Name: Retitrack
• Primary DI: 00860011292104
• Version / Model: CR1
• Company Name: C. Light Technologies, Inc.
• Labeler DUNS: 079570312
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-18
• Public Version: 2
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: f7063edc-74ef-46a2-bf3e-99e9057d5cce

Device Description

Eye movement monitor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HLL	Monitor, eye movement	Ophthalmic	886.1510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64414	Eye/eyelid movement monitoring spectacles/goggles	An electrically-powered optical device intended to monitor eyelid and/or eye movements to assist in the detection of alertness/drowsiness, epileptic seizures, and/or to assist in the identification of vestibular disorders. It consists of a spectacle/goggle-like frame and may include an infrared sensor(s), infrared LED(s), infrared video camera(s), and/or a photodiode(s); it transmits a digital signal to a processing unit, which may use an off-the-shelf video viewing software application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00860011292111	GS1	Case	1	In Commercial Distribution
Primary	00860011292104	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]