Consulting Wallah › Device Explorer › Ophthalmic › Intraocular retractor, single-use
Device Explorer · FDA GUDID · GMDN 46698

Intraocular retractor, single-use

A sterile, 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 self-retaining ring/frame or a small hook-lik

US‑registered devices55in commercial distribution
Companies17labelers on GUDID
Single‑use95%of device records
Sterile95%labelled sterile
Prescription65%Rx‑only share
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Share of device records

Microsurgical Technology, Inc.1629%
Optalmed, Llc713%
Katena Products, Inc.59%
Ambler Surgical Corp.47%
Microvision, Inc.47%
Diamatrix35%
Alcon Laboratories, Inc.24%
Beaver-Visitec International, Inc.24%

Top labelers

CompanyDevicesShare
Microsurgical Technology, Inc.1629%
Optalmed, Llc713%
Katena Products, Inc.59%
Ambler Surgical Corp.47%
Microvision, Inc.47%
Diamatrix35%
Alcon Laboratories, Inc.24%
Beaver-Visitec International, Inc.24%
Oasis Medical, Inc.24%
Sontec Instruments, Inc.24%
Aktive Srl24%
Escalon Medical Corp.12%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Alcon GrieshaberVisitec® I-Ring®Fiber Optic Light GuideN/ADisposable InstrumentsOASIS® Iris ExpanderMST Capsule Retractor, Chang ModificationMalyugin Ring System 2.0, 7.0mmMalyugin Ring System 2.0, 6.25mmMedical Device Iris RetractorMedical Device Anterior Capsule RetractorMalyugin Ring System 6.25mmMalyugin Ring System 7.0mmMAXIRIS AKAHOSHI TW FIBR IRIS/CAP RETRACMAXIRIS AKAHOSHI FLAT IRIS RETRACT PK/5MAXIRIS FLEXIBLE IRIS RETRACTOR PACK/5

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

FDA product codes

CodeNameDevices
HOCClip, Iris Retractor33
HNIRetractor, Ophthalmic9
HOCClip, iris retractor7
HNIRetractor, ophthalmic5
HNQHook, Ophthalmic3
FFORETRACTOR, SELF-RETAINING2

GMDN & GCC registration

  • GMDN code 46698 · non‑implantable
  • Single‑use 95% · sterile 95% · Rx‑only 65% · 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) · 6

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

How many intraocular retractor, single-use products are registered in the US?

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intraocular retractor, single-use", from 17 companies. The largest labeler is Microsurgical Technology, Inc. with 29% of records.

Which FDA product codes apply?

HOC (Clip, Iris Retractor), HNI (Retractor, Ophthalmic), HOC (Clip, iris retractor), HNI (Retractor, 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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