UTAS/RETeval

GUDID 00857901006361

Electroretinograph

Primary Device ID	00857901006361
NIH Device Record Key	9a238ded-397d-4a01-9213-ae1cedbc3fb1
Commercial Distribution Status	In Commercial Distribution
Brand Name	UTAS/RETeval
Version Model Number	UTAS System Type-65
Company DUNS	606234730
Company Name	L K C TECHNOLOGIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00857901006361 [Primary]

GWE	Stimulator, Photic, Evoked Response

Steralize Prior To Use	false
Device Is Sterile	false

00857901006620 - RETeval™	2025-07-09 RETeval visual electrophysiology system - Complete Model for Ukraine only
00857901006637 - RETeval™	2025-07-09 RETeval visual electrophysiology system - DR model for non-USA
00857901006347 - UTAS	2025-06-17
00857901006002 - RETeval™	2023-07-06 Bag of 10 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electrophysiology system.
00857901006491 - UTAS	2022-07-05
00857901006507 - UTAS	2022-07-05
00857901006514 - UTAS	2022-07-05
00857901006521 - UTAS	2022-07-05