EndoSerter ES-1
GUDID 00855934007003
The EndoSerter Corneal Endothelium Delivery Instrument is a device used for delivering a corneal endothelial allograft into the eye. The EndoSerter consists of the instrument’s body and its internal mechanism and carrier. The EndoSerter is a sterile, disposable, single-use only device. When loaded with allograft tissue, rotated, and inserted into the eye the allograft can be deployed in the anterior chamber.
CorneaGen LLC
Donor cornea delivery set| Primary Device ID | 00855934007003 |
| NIH Device Record Key | 58642d14-7621-4826-b480-9d40ebd25704 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoSerter |
| Version Model Number | ES-1 |
| Catalog Number | ES-1 |
| Company DUNS | 080423639 |
| Company Name | CorneaGen LLC |
| 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 | false |
| Manufacturing Date | false |
| 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 | 00855934007003 [Primary] |
FDA Product Code
| OTZ | Graft Insertion Instrument For Endothelial Keratoplasty |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-05-10 |
| Device Publish Date | 2020-11-03 |
Devices Manufactured by CorneaGen LLC
| 00855934007010 - Coronet | 2024-06-24 Recipient Vacuum Trephine - 6.50mm |
| 00855934007027 - Coronet | 2024-06-24 Recipient Vacuum Trephine - 6.75mm |
| 00855934007034 - Coronet | 2024-06-24 Recipient Vacuum Trephine - 7.00mm |
| 00855934007041 - Coronet | 2024-06-24 Recipient Vacuum Trephine - 7.25mm |
| 00855934007058 - Coronet | 2024-06-24 Recipient Vacuum Trephine - 7.50mm |
| 00855934007065 - Coronet | 2024-06-24 Recipient Vacuum Trephine - 7.75mm |
| 00855934007072 - Coronet | 2024-06-24 Recipient Vacuum Trephine - 8.00mm |
| 00855934007089 - Coronet | 2024-06-24 Recipient Vacuum Trephine - 8.25mm |
Trademark Results [EndoSerter]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSERTER 85071577 3956038 Live/Registered |
OCULAR SYSTEMS, LLC 2010-06-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.