RETeval™ RETeval Flicker USA

GUDID 00857901006019

RETeval visual electrophysiology system - Flicker model

L K C TECHNOLOGIES, INC.

Electroretinograph
Primary Device ID00857901006019
NIH Device Record Keyf314b470-265a-43c7-89c8-027f5fe7778c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRETeval™
Version Model NumberRETeval Flicker USA
Catalog NumberRETeval Flicker USA
Company DUNS606234730
Company NameL K C TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone310-840-1992
Emailsupport@lkc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857901006019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-11

On-Brand Devices [RETeval™]

00857901006064RETeval visual electrophysiology system - DR model
00857901006057RETeval visual electrophysiology system - S model
00857901006040RETeval visual electrophysiology system - Complete model
00857901006033RETeval visual electrophysiology system - Complete model
00857901006026RETeval visual electrophysiology system - Flicker model
00857901006019RETeval visual electrophysiology system - Flicker model
20857901006006Bag of 25 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electr
00857901006316Bag of 25 pairs (1-right & 1-left per pair) of Small electrodes for use with the RETeval visual
00857901006477RETeval visual electrophysiology system - Complete model w/o Electrodes
00857901006460RETeval visual electrophysiology system - Complete model w/o Electrodes
00857901006453RETeval visual electrophysiology system - Complete model for Brazil
00857901006446RETeval visual electrophysiology system - Complete model for China
00857901006439RETeval visual electrophysiology system - Complete model for Germany
00857901006002Bag of 10 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electr

Trademark Results [RETeval]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RETEVAL
RETEVAL
85609540 4332869 Live/Registered
LKC Technologies, Inc.
2012-04-26

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