Consulting Wallah › Device Explorer › Other devices › Corneal trephine, reusable
Device Explorer · FDA GUDID · GMDN 14148

Corneal trephine, reusable

An ophthalmic surgical blade designed to cut and remove circular sections of the cornea (corneal buttons) and/or sclera from a patient to prepare for graft implantation, or from cadaveric donors to obtain grafts. It is typically a sharp, beveled, hollow cylind

US‑registered devices131in commercial distribution
Companies10labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Katena Products, Inc.8061%
Ambler Surgical Corp.1915%
Crestpoint Management Limited129%
Medicon Eg. Chirurgiemechaniker-Genossenschaft108%
Geuder Aktiengesellschaft32%
Aspen Surgical Products, Inc.22%
Integra Lifesciences Production Corporation22%
Boss Instruments, Ltd., Inc.11%

Top labelers

CompanyDevicesShare
Katena Products, Inc.8061%
Ambler Surgical Corp.1915%
Crestpoint Management Limited129%
Medicon Eg. Chirurgiemechaniker-Genossenschaft108%
Geuder Aktiengesellschaft32%
Aspen Surgical Products, Inc.22%
Integra Lifesciences Production Corporation22%
Boss Instruments, Ltd., Inc.11%
Med Saver, Inc.11%
Avalign Technologies, Inc.11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N.A.MediconBOSS InstrumentsSymmetry CastroviejoELLIOT SCLERAL TREPHINE BLADE 2MMELLIOT SCLERAL TREPHINE BLADE 1.5MMELLIOT SCLERAL TREPHINE BLADE 1MMOLSON TREPHINE BLADE 9.5MMOLSON TREPHINE BLADE 9.25MMOLSON TREPHINE BLADE 9.0MMOLSON TREPHINE BLADE 8.75MMOLSON TREPHINE BLADE 8.5MMOLSON TREPHINE BLADE 8.25MMOLSON TREPHINE BLADE 8.0MMOLSON TREPHINE BLADE 7.75MMOLSON TREPHINE BLADE 7.5MM

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

FDA product codes

CodeNameDevices
HRHTrephine, manual, ophthalmic97
HRHTrephine, Manual, Ophthalmic15
HNDSpatula, ophthalmic8
HNQHook, ophthalmic6
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES4
HNZCurette, ophthalmic3

GMDN & GCC registration

  • GMDN code 14148 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 89% · 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

Lumen/Inner Diameter (Millimeter) · 49Width (Millimeter) · 4Depth (Millimeter) · 4Outer Diameter (Millimeter) · 3

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

How many corneal trephine, reusable products are registered in the US?

131 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Corneal trephine, reusable", from 10 companies. The largest labeler is Katena Products, Inc. with 61% of records.

Which FDA product codes apply?

HRH (Trephine, manual, ophthalmic), HRH (Trephine, Manual, Ophthalmic), HND (Spatula, ophthalmic), 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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