Identity
- Trade Name
- EndoSerter-PL FDA UDI
- Generic Name
- Donor cornea delivery set FDA UDI
- Device Name
- The EndoSerter-PL is a sterile, single use, hand held, manual ophthalmic surgical instrument. It is used to pre-load a processed donor corneal endothelial allograft for storage and transportation to the ophthalmic surgeon and to deliver the allograft into the anterior chamber of the eye during corneal surgery. It is designed to deliver a corneal endothelial allograft into the eye during corneal endothelial keratoplasty. The loading and storage of donor tissue for transport to the surgeon can be performed by any trained eye bank technician. Users of this instrument are experienced ophthalmic surgeons in a healthcare facility or hospital. Under no situation will empty EndoSerter-PL units be supplied directly to surgeons for loading. FDA UDI
- Model / Reference
- ES-PL FDA UDI
- Description
- The EndoSerter-PL is a sterile, single use, hand held, manual ophthalmic surgical instrument. It is used to pre-load a processed donor corneal endothelial allograft for storage and transportation to the ophthalmic surgeon and to deliver the allograft into the anterior chamber of the eye during corneal surgery. It is designed to deliver a corneal endothelial allograft into the eye during corneal endothelial keratoplasty. The loading and storage of donor tissue for transport to the surgeon can be performed by any trained eye bank technician. Users of this instrument are experienced ophthalmic surgeons in a healthcare facility or hospital. Under no situation will empty EndoSerter-PL units be supplied directly to surgeons for loading. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855934007485 FDA UDI
- 510(k) Number
- K203586 FDA UDI
- FDA Product Code
- OTZ FDA UDI
- GMDN Term
- Donor cornea delivery set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Donor cornea delivery set
EndoSerter-PL by CorneaGen — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CorneaGen
Sources (1)
- FDA UDI 849bf5cb-c22d-4c89-9b5c-d7316c294144 34 fields · synced Jun 8, 2026