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Device Explorer · FDA GUDID · GMDN 46252

Corneal trephine handle

A hand-held, ophthalmic surgical device used to hold an exchangeable trephine (cylindrical cutting blade) so that it can be manually rotated with downward pressure by a surgeon in order to cut and remove circular pieces of corneal tissue (corneal buttons) or s

US‑registered devices68in commercial distribution
Companies5labelers on GUDID
Single‑use4%of device records
Sterile4%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Katena Products, Inc.6190%
Surgistar, Inc.34%
Steris Corporation23%
Med Saver, Inc.11%
Avalign Technologies, Inc.11%

Top labelers

CompanyDevicesShare
Katena Products, Inc.6190%
Surgistar, Inc.34%
Steris Corporation23%
Med Saver, Inc.11%
Avalign Technologies, Inc.11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SURGISTARAQUAVELLA KPRO TISSUE HOLDER 11MMAQUAVELLA KPRO TISSUE HOLDER 10MMAQUAVELLA KPRO TISSUE HOLDER 8.5MMAQUAVELLA KPRO TREPHINE HOLDER 7MMELLIOT SCLERAL TREPHINE HANDLEOLSON CENTERING DEVICE 7MM MICROM DEVICECORNEAL TREPHINE HANDLE 9.5MMCORNEAL TREPHINE HANDLE 9MMCORNEAL TREPHINE HANDLE 8.7MMCORNEAL TREPHINE HANDLE 8.5MMPANNU CROSS HAIR MARKER 8.5MMCORNEAL TREPHINE HANDLE 8.2MMPANNU CROSS HAIR MARKER 8.2MMCORNEAL TREPHINE HANDLE 8MMPANNU CROSS HAIR MARKER 8MM

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, ophthalmic41
HNQHook, ophthalmic6
HNWDilator, lachrymal4
GDZHandle, Scalpel3
HNXDepressor, orbital3
HNLProbe, lachrymal3

GMDN & GCC registration

  • GMDN code 46252 · non‑implantable
  • Single‑use 4% · sterile 4% · Rx‑only 96% · 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

Outer Diameter (Millimeter) · 28

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

How many corneal trephine handle products are registered in the US?

68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Corneal trephine handle", from 5 companies. The largest labeler is Katena Products, Inc. with 90% of records.

Which FDA product codes apply?

HRH (Trephine, manual, ophthalmic), HNQ (Hook, ophthalmic), HNW (Dilator, lachrymal), GDZ (Handle, Scalpel)

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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