Fine-Thornton Fixation Ring 13mm

FDA UDI

Class I (US FDA UDI)

by Katena Products, Inc.

Identity

Trade Name: FINE-THORNTON FIXATION RING 13MM FDA UDI
Generic Name: Eyeball fixation instrument, reusable FDA UDI
Device Name: FINE-THORNTON FIXATION RING 13MM FDA UDI
Model / Reference: AE-2198 FDA UDI
Description: FINE-THORNTON FIXATION RING 13MM FDA UDI

Identifiers

Catalog Number: AE-2198 FDA UDI
Primary DI / UDI-DI: 00841668128619 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 13 Millimeter FDA UDI

Category: Eyeball fixation instrument, reusable

Fine-Thornton Fixation Ring 13mm 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.

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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

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Manufacturer

Manufacturer: Katena Products, Inc.

Sources (1)

FDA UDI f44be8e3-9c76-49f7-bfb6-b76491c5ba15 36 fields · synced Jun 12, 2026