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Device Explorer · FDA GUDID · GMDN 36249

Orthopaedic bur, reusable

A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the

US‑registered devices2,619in commercial distribution
Companies50labelers on GUDID
Single‑use16%of device records
Sterile48%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Gebr. Brasseler Gmbh & Co. Kg1,02739%
Medtronic Xomed, Inc.33113%
Synthes Gmbh2218%
Karl Storz Gmbh & Co. Kg2018%
Aesculap Ag1817%
Medartis Ag1064%
Versah, Llc632%
Gsource Llc552%

Top labelers

CompanyDevicesShare
Gebr. Brasseler Gmbh & Co. Kg1,02739%
Medtronic Xomed, Inc.33113%
Synthes Gmbh2218%
Karl Storz Gmbh & Co. Kg2018%
Aesculap Ag1817%
Medartis Ag1064%
Versah, Llc632%
Gsource Llc552%
Richard Wolf Gmbh532%
In2Bones Usa, Llc512%
In2Bones351%
Nouvag Ag281%

Company = labeler of record on GUDID. 50 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

n/aInion Hexalon™ InstrumentationUniglide Unicondylar Knee ProsthesisDe Soutter MedicalT2PROFYLENAN/ABone drillHermann Medizintechnik GmbHVERTEBRISTIPCONTROLn.a.ELAN 4CRANIOPLATEAESCULAP

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

FDA product codes

CodeNameDevices
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY853
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)452
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP411
EQJBUR, EAR, NOSE AND THROAT390
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES322
GFFBur, Surgical, General & Plastic Surgery228

GMDN & GCC registration

  • GMDN code 36249 · non‑implantable
  • Single‑use 16% · sterile 48% · Rx‑only 93% · 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) · 535Length (Millimeter) · 170Length (Centimeter) · 55Angle (degree) · 43Width (Millimeter) · 3Length (Inch) · 1

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

How many orthopaedic bur, reusable products are registered in the US?

2,619 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bur, reusable", from 50 companies. The largest labeler is Gebr. Brasseler Gmbh & Co. Kg with 39% of records.

Which FDA product codes apply?

GFF (BUR, SURGICAL, GENERAL & PLASTIC SURGERY), HBE (DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)), ERL (DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP), EQJ (BUR, EAR, NOSE AND THROAT)

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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