Identity
- Trade Name
- Oph.Hook FDA UDI
- Generic Name
- Eyeball fixation instrument, reusable FDA UDI
- Device Name
- Fine/Thornton II Fix Ring 13mm W/Swivel FDA UDI
- Model / Reference
- 08-15218 FDA UDI
- Description
- Fine/Thornton II Fix Ring 13mm W/Swivel FDA UDI
Identifiers
- Catalog Number
- 08-15218 FDA UDI
- Primary DI / UDI-DI
- 00841668120828 FDA UDI
- FDA Product Code
- HNQ FDA UDI
- GMDN Term
- Eyeball fixation instrument, reusable 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
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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 13 Millimeter FDA UDI
Category: Eyeball fixation instrument, reusable
Oph.Hook by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eyeball fixation instrument, reusable.
- Flieringa Scleral Fixation Ring, 13mm — KATALYST SURGICAL, LLC · Class I
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Rumex — Rumex International Co. · Class I
- Flieringa Scleral Fixation Ring, 17mm Diameter — AURORA SURGICAL, LLC · Class I
- Flieringa Scleral Fixation Ring, 24mm — KATALYST SURGICAL, LLC · Class I
- Flieringa Scleral Fixation Ring, 9mm — KATALYST SURGICAL, LLC · Class I
- Titanium Castroviejo Caliper — KATALYST SURGICAL, LLC · 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 dd5c4e48-0773-497f-8346-82ca562ce74c 36 fields · synced Jun 12, 2026