General-purpose ophthalmic hook, reusable

FDA UDI

Class I (US FDA UDI)

by Fci S A S Fci 20 22

Identity

Trade Name: General-purpose ophthalmic hook, reusable FDA UDI
Generic Name: Ocular hook/spatula/manipulator, reusable FDA UDI
Device Name: A hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a reusable device. FDA UDI
Model / Reference: RITLENG HOOK FDA UDI
Description: A hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a reusable device. FDA UDI

Identifiers

Catalog Number: S1.1480U FDA UDI
Primary DI / UDI-DI: 03760087126259 FDA UDI
FDA Product Code: HNQ FDA UDI
GMDN Term: Ocular hook/spatula/manipulator, 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

Yes

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ocular hook/spatula/manipulator, reusable

General-purpose ophthalmic hook, reusable by Fci S A S Fci 20 22 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ocular hook/spatula/manipulator, reusable.

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Rumex — Rumex International Co. · Class I
Ophthalmic Spatula — CILITA Ltd. · Class I
Rumex — Rumex International Co. · Class I
Sklar — Sklar Corporation · Class I
Surgical Direct — SURGICAL DIRECT, 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

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Manufacturer

Manufacturer: Fci S A S Fci 20 22

Sources (1)

FDA UDI 9fc857af-7be3-41d1-a68a-f0aedcbb7da2 35 fields · synced Jun 6, 2026