FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoSerter
DI: 00855934007003
·
Model: ES-1
·
CORNEAGEN INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndoSerter
- Primary DI
- 00855934007003
- Version / Model
- ES-1
- Catalog Number
- ES-1
- Company Name
- CORNEAGEN INC.
- Labeler DUNS
- 116934664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-03
- Public Version
- 1
- Public Version Date
- 2020-11-11
- Public Version Status
- New
- Public Device Record Key
- 58642d14-7621-4826-b480-9d40ebd25704
Device Description
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.
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OTZ | Graft Insertion Instrument For Endothelial Keratoplasty | Ophthalmic | 886.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48161 | Donor cornea delivery set | A collection of sterile devices designed to hold and deliver prepared donor endothelial tissue for transplantation into a recipient eye following the removal of Descemet's membrane and dysfunctional endothelium from the patient's cornea during ophthalmic surgery. It typically consists of a preparation base, a cartridge which holds the tissue in a double-coil preventing the surfaces/edges from folding and touching, and an introducer to manually position the cartridge from where the tissue is glided into the eye in correct orientation to unfold. This set is only used for partial replacement of dysfunctional corneal cell layers and not for total cornea replacement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855934007003 | GS1 |