Consulting Wallah › Device Explorer › Ophthalmic › Intraocular retractor, reusable
Device Explorer · FDA GUDID · GMDN 63431

Intraocular retractor, reusable

A dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention b

US‑registered devices155in commercial distribution
Companies19labelers on GUDID
Single‑use15%of device records
Sterile1%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Bausch & Lomb Incorporated2919%
Katena Products, Inc.2516%
Astura Medical2315%
Walcott Rx Product Inc149%
Rumex International Corp.138%
Surgical Direct, Inc.128%
Crestpoint Management Limited96%
Avalign Technologies, Inc.64%

Top labelers

CompanyDevicesShare
Bausch & Lomb Incorporated2919%
Katena Products, Inc.2516%
Astura Medical2315%
Walcott Rx Product Inc149%
Rumex International Corp.138%
Surgical Direct, Inc.128%
Crestpoint Management Limited96%
Avalign Technologies, Inc.64%
Novo Surgical, Inc.64%
Hayden Medical, Inc.43%
Med Saver, Inc.32%
Geuder Aktiengesellschaft21%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Duckworth & KentN.A.N/AKRATZ IOL MANIPULATORLEWICKY IOL MANIPULATOR HOOKLITTLE IOL MANIPULATOR STRAIGHTKUGLEN IRIS HOOK ANGLEDKUGLEN IRIS HOOK STRAIGHTBEEHLER IRRIGATING PUPIL EXPANDERKNOLLE IRIS HOOKHIRSCHMAN IRIS HOOKGRAETHER IRIS RETRACTOR ANGLEDGRAETHER IRIS RETRACTOR STRAIGHTOph.HookOphthalmic HookIris Retractor

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HNIRetractor, Ophthalmic56
HNIRetractor, ophthalmic27
GADRetractor23
HNQHook, ophthalmic22
HOCClip, iris retractor13
HNDSpatula, Ophthalmic9

GMDN & GCC registration

  • GMDN code 63431 · non‑implantable
  • Single‑use 15% · sterile 1% · Rx‑only 66% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 8Length (Inch) · 1

Use these as the dimensions to specify in a tender line.

How many intraocular retractor, reusable products are registered in the US?

155 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intraocular retractor, reusable", from 19 companies. The largest labeler is Bausch & Lomb Incorporated with 19% of records.

Which FDA product codes apply?

HNI (Retractor, Ophthalmic), HNI (Retractor, ophthalmic), GAD (Retractor), HNQ (Hook, ophthalmic)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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