Consulting Wallah › Device Explorer › Ophthalmic › Ophthalmic knife, single-use
Device Explorer · FDA GUDID · GMDN 46741

Ophthalmic knife, single-use

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 devices1,097in commercial distribution
Companies25labelers on GUDID
Single‑use96%of device records
Sterile99%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Mani, Inc.23421%
Feather Safety Razor Co., Ltd.969%
Diamatrix848%
Ovation International817%
Aktive Srl767%
Oasis Medical, Inc.696%
Surgical Specialties México, S. De R.L. De C.V.616%
Ambler Surgical Corp.616%

Top labelers

CompanyDevicesShare
Mani, Inc.23421%
Feather Safety Razor Co., Ltd.969%
Diamatrix848%
Ovation International817%
Aktive Srl767%
Oasis Medical, Inc.696%
Surgical Specialties México, S. De R.L. De C.V.616%
Ambler Surgical Corp.616%
Makvin Surgical Llc585%
Psi/Eye-Ko, Inc.515%
Alcon Laboratories, Inc.484%
Microspecialities, Inc.424%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Windsor KnifeMICRO FEATHER DISPOSABLE OPHTHALMIC SCALPEL withMICRO FEATHER SAFESHIELD DISPOSABLE OPHTHALMIC SVIA360 Surgical SystemKahook Dual Blade GlideZiplyft Upper Eyelid Lift KitZiplyftGoniotome HandpieceGoniotome +I/A HandpieceiAccessMakEdgeMSPStab StraightSharpoint2.4 mm SLIT ANGLED, DOUBLE-BEVEL, GUARDEDSlit angled, Double Bevel

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

FDA product codes

CodeNameDevices
HNNKnife, Ophthalmic619
HNNKnife, ophthalmic492
GESBLADE, SCALPEL23
HODClamp, Eyelid, Ophthalmic2
HNRForceps, Ophthalmic2
MRHPump, infusion, ophthalmic1

GMDN & GCC registration

  • GMDN code 46741 · non‑implantable
  • Single‑use 96% · sterile 99% · Rx‑only 52% · 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) · 49Width (Millimeter) · 21Angle (degree) · 15Needle Gauge (Gauge) · 13Width (Inch) · 9

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

How many ophthalmic knife, single-use products are registered in the US?

1,097 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic knife, single-use", from 25 companies. The largest labeler is Mani, Inc. with 21% of records.

Which FDA product codes apply?

HNN (Knife, Ophthalmic), HNN (Knife, ophthalmic), GES (BLADE, SCALPEL), HOD (Clamp, Eyelid, 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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