Identity
- Trade Name
- THORNTON RADIAL INCISION MARKER 6 BLADES FDA UDI
- Generic Name
- Corneal marker, reusable FDA UDI
- Device Name
- THORNTON RADIAL INCISION MARKER 6 BLADES FDA UDI
- Model / Reference
- AE-2750L FDA UDI
- Description
- THORNTON RADIAL INCISION MARKER 6 BLADES FDA UDI
Identifiers
- Catalog Number
- AE-2750L FDA UDI
- Primary DI / UDI-DI
- 00841668130872 FDA UDI
- FDA Product Code
- HMR FDA UDI
- GMDN Term
- Corneal marker, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Corneal marker, reusable
Thornton Radial Incision Marker 6 Blades by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Corneal marker, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- MR PHACO — Crestpoint Management Ltd. · Class I
- Hoffer Optic Zone Marker, with Cross Hairs, 3.0mm — KATALYST SURGICAL, LLC · Class I
- Double End Martinel Corneal Dissector — DAUD JEE MFG. CO · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Mastel Precision Surgical Instruments, Inc. — MASTEL SURGICAL INC. · Class I
- Epsilon USA — EPSILON EYE CARE PRIVATE LIMITED · Class I
- Mastel Precision Surgical Instruments, Inc. — MASTEL SURGICAL INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Katena Products, Inc.
Sources (1)
- FDA UDI bdce1cbe-61e3-4930-80df-9c9a4bf40882 35 fields · synced Jun 12, 2026