Disposable Iris Retract

FDA UDI

Class I (US FDA UDI)

by Katena Products, Inc.

Identity

Trade Name: Disposable Iris Retract FDA UDI
Generic Name: Intraocular retractor, single-use FDA UDI
Device Name: FLEXIBLE IRIS RETRACTORS 1 PK of 5 FDA UDI
Model / Reference: K20-3890 FDA UDI
Description: FLEXIBLE IRIS RETRACTORS 1 PK of 5 FDA UDI

Identifiers

Catalog Number: K20-3890 FDA UDI
Primary DI / UDI-DI: 00841668114339 FDA UDI
FDA Product Code: HOC FDA UDI
GMDN Term: Intraocular retractor, single-use 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

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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Intraocular retractor, single-use

Disposable Iris Retract by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraocular retractor, single-use.

Diamatrix Ltd — Diamatrix · Class I
Medical Device Anterior Capsule Retractor — MICROSURGICAL TECHNOLOGY, INC. · Class I
Malyugin Ring System 7.0mm — MICROSURGICAL TECHNOLOGY, INC. · Class I
Medical Device Anterior Capsule Retractor — MICROSURGICAL TECHNOLOGY, INC. · Class I
Malyugin Ring System 6.25mm — MICROSURGICAL TECHNOLOGY, INC. · Class I
Fiber Optic Light Guide — ESCALON MEDICAL CORP · Class I
APX 200 — APX OPHTHALMOLOGY LTD · Class I
Ambler Surgical — Ambler 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 3f06475a-dd02-462f-81e8-ab55e912658e 35 fields · synced Jun 12, 2026