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Coronet

FDA UDI

Class I (US FDA UDI)

by CorneaGen

Identity

Trade Name
Coronet FDA UDI
Generic Name
Corneal punch set FDA UDI
Device Name
Donor Trephine Vacuum Punch - 8.00mm FDA UDI
Model / Reference
SLS-20-800 FDA UDI
Description
Donor Trephine Vacuum Punch - 8.00mm FDA UDI

Identifiers

Primary DI / UDI-DI
00855934007218 FDA UDI
FDA Product Code
HRH FDA UDI
GMDN Term
Corneal punch set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4350 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Corneal punch set

Coronet by CorneaGen — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Corneal punch set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CorneaGen

Sources (1)

  • FDA UDI 15ebb39b-f12b-4b56-b30a-20368842c146 33 fields · synced May 31, 2026