Identity
- Trade Name
- RON YEOH GAUGE 4 SLOTS 5 DEGREE FDA UDI
- Generic Name
- Corneal trephine, reusable FDA UDI
- Device Name
- RON YEOH GAUGE 4 SLOTS 5 DEGREE FDA UDI
- Model / Reference
- AE-1595 FDA UDI
- Description
- RON YEOH GAUGE 4 SLOTS 5 DEGREE FDA UDI
Identifiers
- Catalog Number
- AE-1595 FDA UDI
- Primary DI / UDI-DI
- 00841668127940 FDA UDI
- FDA Product Code
- HMR FDA UDI
- GMDN Term
- Corneal trephine, 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 trephine, reusable
Ron Yeoh Gauge 4 Slots 5 Degree by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Corneal trephine, reusable.
- Symmetry Castroviejo — SYMMETRY SURGICAL INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- MR PHACO — Crestpoint Management Ltd. · Class I
- MR PHACO — Crestpoint Management Ltd. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- MR PHACO — Crestpoint Management Ltd. · 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 8b02fbb4-b968-4760-a6eb-a10cae629b26 35 fields · synced Jun 12, 2026