Consulting Wallah › Device Explorer › Other devices › Corneal marker, single-use
Device Explorer · FDA GUDID · GMDN 12442

Corneal marker, single-use

A manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.

US‑registered devices79in commercial distribution
Companies7labelers on GUDID
Single‑use46%of device records
Sterile16%labelled sterile
Prescription44%Rx‑only share
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Share of device records

Surgical Direct, Inc.4051%
Novo Surgical, Inc.2228%
Moria Sa1013%
Anmuth Medical International, Llc34%
Sterimedix Limited23%
Oasis Medical, Inc.11%
Krishna Imports Inc11%

Top labelers

CompanyDevicesShare
Surgical Direct, Inc.4051%
Novo Surgical, Inc.2228%
Moria Sa1013%
Anmuth Medical International, Llc34%
Sterimedix Limited23%
Oasis Medical, Inc.11%
Krishna Imports Inc11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ONESurgical Marking PenNovo Surgical Inc.Stephens InstrumentsSurgical DirectScleral MarkersAnmuth Medical International

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

FDA product codes

CodeNameDevices
HMRMarker, ocular38
FZZMarker, Skin24
HMRMarker, Ocular13
FZZMARKER, SKIN3
MEDSterilant, Medical Devices2
HMQMarker, sclera1

GMDN & GCC registration

  • GMDN code 12442 · non‑implantable
  • Single‑use 46% · sterile 16% · Rx‑only 44% · 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 (Inch) · 3

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

How many corneal marker, single-use products are registered in the US?

79 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Corneal marker, single-use", from 7 companies. The largest labeler is Surgical Direct, Inc. with 51% of records.

Which FDA product codes apply?

HMR (Marker, ocular), FZZ (Marker, Skin), HMR (Marker, Ocular), FZZ (MARKER, SKIN)

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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