Home GUDID 00860011292111 Retitrack
Primary DI 00860011292111
Brand Retitrack
Company C. Light Technologies, Inc.
Model CR1
Device description Eye movement monitor
Published 2024-10-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HLL Monitor, eye movement
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HLL Monitor, Eye Movement Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860011292111 Package GS1 1 In Commercial Distribution 00860011292104 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860011292111 00860011292111 860011292111 0860011292111 00860011292104 00860011292104 860011292104 0860011292104
GMDN Terms# Term, Definition table Term Definition 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 disorder. 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.
Sterilization Methods# Method table Method High-level Disinfectant
Regulatory Flags# DUNS number 079570312 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860011292104 Retitrack CR1 2024-10-18
Other Devices Sharing Product Codes# 
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