CorneaGen

FDA Device Registration & Listing · Winston Salem, NC, US · Registration 3005357288

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005357288
FEI Number
3005357288
Entity Name
CorneaGen
City/State/Country
Winston Salem, NC, US
Establishment Address
101 N Chestnut St Ste 303, Winston Salem, NC 27101, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
CorneaGen (Owner Number: 10046718)
Owner / Operator Contact Address
101 N Chestnut St, Suite 303, Winston Salem, NC 27101, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K090626
PMA Number
N/A

All Registered Proprietary Names

Pre-Loaded EndoSerter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OTZ Graft Insertion Instrument For Endothelial Keratoplasty Ophthalmic Class 1 886.4300 2022-12-30
OTZ Graft Insertion Instrument For Endothelial Keratoplasty Ophthalmic Class 1 886.4300 2014-05-02

Official Correspondent

Nora Brown

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CorneaGen
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005357288. Last updated year: 2026. Please use registration number 3005357288 when referencing this establishment in official correspondence.
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