UTAS

GUDID 00857901006309

L K C TECHNOLOGIES, INC.

Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph

Primary Device ID	00857901006309
NIH Device Record Key	15b487f3-0bb3-4297-b3dd-ca7ed865d056
Commercial Distribution Status	In Commercial Distribution
Brand Name	UTAS
Version Model Number	UTAS System Type-62
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com
Phone	301-840-1992
Email	support@lkc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857901006309 [Primary]

FDA Product Code

GWE	Stimulator, Photic, Evoked Response

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-10-22
Device Publish Date	2018-09-19

On-Brand Devices [UTAS]

00857901006309	UTAS System Type-62
00857901006293	4CH/AC, BigShot, UV, CRT
00857901006286	UTAS System Type-72
00857901006279	UTAS System Type-62
00857901006262	UTAS System Type-98
00857901006255	UTAS System Type-10
00857901006248	UTAS System Type-39
00857901006231	4-channel AC Coupled UBA
00857901006224	UTAS System Type-35
00857901006217	UTAS System Type-48
00857901006200	UTAS System Type-40
00857901006194	UTAS System Type-14
00857901006187	UTAS System Type-16
00857901006170	UTAS System Type-12
00857901006088	UTAS System Type-9
00857901006354	6CH Pattern/Multi-Focal Only
00857901006378	UTAS System Type-10
00857901006422	UTAS System Type-54 Dark Adapt
00857901006415	UTAS System Type-53 Pattern/Multifocal/SunBurst/RE
00857901006408	UTAS System Type-52 Pattern/Multifocal/SunBurst
00857901006392	UTAS System Type-51 Pattern/Multifocal/RETeval
00857901006385	UTAS System Type-50 Pattern/Multifocal
00857901006606	6CH Pattern/Multi-Focal Only
00857901006590	UTAS System Type-52L Pattern/Multifocal/SunBurst
00857901006583	UTAS System Type-50L Pattern/Multifocal
00857901006576	UTAS System Type-48L
00857901006569	4CH/AC, BigShot, UV, CRT
00857901006552	UTAS System Type-41L
00857901006545	UTAS System Type-40L
00857901006538	UTAS System Type-39L
00857901006521	UTAS System Type-12L
00857901006514	UTAS System Type-11L
00857901006507	UTAS System Type-10L
00857901006491	UTAS System Type-9L