Consulting Wallah › Device Explorer › Other devices › Corneal bur system, battery-powered
Device Explorer · FDA GUDID · GMDN 42443

Corneal bur system, battery-powered

"An assembly of devices designed for abrasion of the cornea and other eye tissues. It typically consists of a small, battery-powered rotatory handpiece with a motor, and a small shaft made of a hard metal such as steel (i.e., a bur) that may include a diamond

US‑registered devices69in commercial distribution
Companies6labelers on GUDID
Single‑use32%of device records
Sterile7%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Katena Products, Inc.2435%
Med Saver, Inc.2333%
Innovative Excimer Solutions913%
Sontec Instruments, Inc.69%
Beaver-Visitec International, Inc.57%
The Alger Co Inc23%

Top labelers

CompanyDevicesShare
Katena Products, Inc.2435%
Med Saver, Inc.2333%
Innovative Excimer Solutions913%
Sontec Instruments, Inc.69%
Beaver-Visitec International, Inc.57%
The Alger Co Inc23%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ophtho-Burr®ALGERBRUSH IIALGERBRUSH II PTERYGIUM 3.5 RND MED DIAMALGERBRUSH RUST RING REM CHUCK .5MM BURRYOSHIDA DIAMOND COATED BURRALGERBRUSH CORN RUST RING REM BURR 1.0MMALGERBRUSH RUST RING REM BURR 0.5MMALGERBRUSH CORN RUST RING REM 0.5MM BURRBurrAmoils Epithelial ScrubberMSI Precision Specialty InstrumentsALGERBRUSH II PTERYGIUM BURRALGERBRUSH DIAMOND BURRALGERBRUSH DIAMOND FINE GRIT BURRALGERBRUSH II CORNEAL RUST RING REMOVERVisitec®

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

FDA product codes

CodeNameDevices
OHWBurr, corneal, battery powered, rust ring removal39
HOGBurr, Corneal, Battery-Powered16
HOGBurr, corneal, battery-powered8
OHWBurr, Corneal, Battery Powered, Rust Ring Removal5
HNIRetractor, Ophthalmic1
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea1

GMDN & GCC registration

  • GMDN code 42443 · non‑implantable
  • Single‑use 32% · sterile 7% · Rx‑only 97% · 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) · 4Outer Diameter (Millimeter) · 4Circumference (Millimeter) · 3

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

How many corneal bur system, battery-powered products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Corneal bur system, battery-powered", from 6 companies. The largest labeler is Katena Products, Inc. with 35% of records.

Which FDA product codes apply?

OHW (Burr, corneal, battery powered, rust ring removal), HOG (Burr, Corneal, Battery-Powered), HOG (Burr, corneal, battery-powered), OHW (Burr, Corneal, Battery Powered, Rust Ring Removal)

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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