Consulting Wallah › Device Explorer › Ophthalmic › Ophthalmic knife, reusable
Device Explorer · FDA GUDID · GMDN 32764

Ophthalmic knife, reusable

A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and

US‑registered devices2,069in commercial distribution
Companies38labelers on GUDID
Single‑use1%of device records
Sterile5%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Ambler Surgical Corp.38319%
Walcott Rx Product Inc20510%
Katena Products, Inc.1969%
Med Saver, Inc.1909%
Mastel Surgical Inc.1477%
Aurora Surgical, Llc1045%
Katalyst Surgical Llc904%
Anton Meyer & Co. Ag814%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.38319%
Walcott Rx Product Inc20510%
Katena Products, Inc.1969%
Med Saver, Inc.1909%
Mastel Surgical Inc.1477%
Aurora Surgical, Llc1045%
Katalyst Surgical Llc904%
Anton Meyer & Co. Ag814%
Diamatrix734%
Psi/Eye-Ko, Inc.643%
Feather Safety Razor Co., Ltd.623%
Rumex International Corp.553%

Company = labeler of record on GUDID. 38 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Alcon GrieshaberAmidiaMeycoSurtexDuckworth & KentMICRO FEATHER OPHTHALMIC SCALPEL with aluminum hBausch + LombN.A.AESCULAPMediconMORIABOSS InstrumentsSymmetry SurgicalSymmetry FrancisSuture Trabeculotomy KnifeOph.Knife

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

FDA product codes

CodeNameDevices
HNNKnife, Ophthalmic837
HNNKnife, ophthalmic674
HNQHook, ophthalmic438
EMFKNIFE, SURGICAL73
HRHTrephine, manual, ophthalmic29
HNQHook, Ophthalmic26

GMDN & GCC registration

  • GMDN code 32764 · non‑implantable
  • Single‑use 1% · sterile 5% · Rx‑only 56% · 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

Width (Millimeter) · 57Length (Millimeter) · 51Depth (Millimeter) · 7Length (Inch) · 3Height (Millimeter) · 3Angle (degree) · 1

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

How many ophthalmic knife, reusable products are registered in the US?

2,069 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic knife, reusable", from 38 companies. The largest labeler is Ambler Surgical Corp. with 19% of records.

Which FDA product codes apply?

HNN (Knife, Ophthalmic), HNN (Knife, ophthalmic), HNQ (Hook, ophthalmic), EMF (KNIFE, SURGICAL)

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.

How do I get quotes?

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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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