RETeval™ RETeval Flicker USA

GUDID 00857901006019

RETeval visual electrophysiology system - Flicker model

L K C TECHNOLOGIES, INC.

Electroretinograph

• Primary Device ID: 00857901006019
• NIH Device Record Key: f314b470-265a-43c7-89c8-027f5fe7778c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RETeval™
• Version Model Number: RETeval Flicker USA
• Catalog Number: RETeval Flicker USA
• 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: true
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: 310-840-1992
• Email: support@lkc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857901006019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142567

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-11

On-Brand Devices [RETeval™]

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