RETeval

GUDID 00857901006323

Visual Electrophysiology passive sensing electrode

L K C TECHNOLOGIES, INC.

Electroretinograph electrode

• Primary Device ID: 00857901006323
• NIH Device Record Key: dcb45071-ecff-47da-a7ee-1de2780d0b59
• Commercial Distribution Discontinuation: 2019-10-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RETeval
• Version Model Number: Samll Sensor Strips
• Company DUNS: 606234730
• Company Name: L K C TECHNOLOGIES, INC.
• Device Count: 50
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00857901006316 [Unit of Use]
GS1	00857901006323 [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: 2
• Public Version Date: 2019-10-25
• Device Publish Date: 2019-09-16

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