RETeval™ RETeval Complete USA
GUDID 00857901006033
RETeval visual electrophysiology system - Complete model
L K C TECHNOLOGIES, INC.
Electroretinograph electrode| Primary Device ID | 00857901006033 |
| NIH Device Record Key | e3721e11-601d-4afd-9c17-369001e5c07b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RETeval™ |
| Version Model Number | RETeval Complete USA |
| Catalog Number | RETeval Complete 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 |
| support@lkc.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857901006033 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142567
FDA Product Code
| HLG | Pupillometer, Ac-Powered |
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 |
| 00857901006637 | RETeval visual electrophysiology system - DR model for non-USA |
| 00857901006620 | RETeval visual electrophysiology system - Complete Model for Ukraine only |
Trademark Results [RETeval]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RETEVAL 85609540 4332869 Live/Registered |
LKC Technologies, Inc. 2012-04-26 |
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