RETeval™

Basic Information

• Brand Name: RETeval™
• Primary DI: 20857901006006
• Version / Model: Sensor Strips
• Catalog Number: Sensor Strips
• Company Name: L K C TECHNOLOGIES, INC.
• Labeler DUNS: 606234730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2019-10-21
• Public Version: 2
• Public Version Date: 2023-12-13
• Public Version Status: Update
• Public Device Record Key: dcbb71ec-2acb-4ea8-9a1e-a84cdc242ed3

Device Description

Box of 25 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electrophysiology system.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11460	Electroretinograph electrode	A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20857901006006	GS1
Unit of Use	00857901006002	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K142567	000