UTAS/RETeval

GUDID 00857901006361

6CH Pattern/Multi-Focal System with RETeval Complete

L K C TECHNOLOGIES, INC.

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

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
• 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	00857901006361 [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: 2021-03-19
• Device Publish Date: 2021-03-11

Devices Manufactured by L K C TECHNOLOGIES, INC.

• 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
• 00857901006538 - UTAS: 2022-07-05
• 00857901006545 - UTAS: 2022-07-05
• 00857901006552 - UTAS: 2022-07-05