Consulting Wallah › Device Explorer › Other devices › Orthopaedic bur, single-use
Device Explorer · FDA GUDID · GMDN 45553

Orthopaedic bur, single-use

A sterile, 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 pro

US‑registered devices17,764in commercial distribution
Companies41labelers on GUDID
Single‑use99%of device records
Sterile98%labelled sterile
Prescription37%Rx‑only share
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Share of device records

Razek Equipamentos Ltda11,20663%
Medtronic Powered Surgical Solutions3,22318%
Nakanishi Inc.5943%
Conmed Corporation4232%
Aesculap Ag3792%
Peter Brasseler Holdings, Llc3222%
Omega Surgical Instruments Inc2952%
Zethon Limited2371%

Top labelers

CompanyDevicesShare
Razek Equipamentos Ltda11,20663%
Medtronic Powered Surgical Solutions3,22318%
Nakanishi Inc.5943%
Conmed Corporation4232%
Aesculap Ag3792%
Peter Brasseler Holdings, Llc3222%
Omega Surgical Instruments Inc2952%
Zethon Limited2371%
Medline Industries, Inc.2121%
Stryker Corporation1651%
Gebr. Brasseler Gmbh & Co. Kg1371%
De Soutter Medical Limited1131%

Company = labeler of record on GUDID. 41 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AMakoC2CStrykerNASurgify Halo 5.4 mm ExtendableSurgify Halo - 5.4 mm - LongSurgify Halo - 5.4 mm - MediumSurgify Halo 5.4 mm LongSurgify Halo 5.4 mm MediumSurgify Halo 5.4 mm ShortSurgify Halo 4.0 mm ExtendableSurgify Halo 4.0 mm LongSurgify Halo 4.0 mm ShortSurgify Halo 3.0 mm ExtendableSurgify Halo 3.0 mm Long

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

FDA product codes

CodeNameDevices
LXHOrthopedic Manual Surgical Instrument11,197
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY2,245
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1,871
HBBMOTOR, DRILL, PNEUMATIC1,487
GFFBur, Surgical, General & Plastic Surgery716
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP674

GMDN & GCC registration

  • GMDN code 45553 · non‑implantable
  • Single‑use 99% · sterile 98% · Rx‑only 37% · 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) · 401Length (Millimeter) · 218Width (Millimeter) · 10Length (Centimeter) · 6Angle (degree) · 6Outer Diameter (Inch) · 1

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

How many orthopaedic bur, single-use products are registered in the US?

17,764 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bur, single-use", from 41 companies. The largest labeler is Razek Equipamentos Ltda with 63% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), GFF (BUR, SURGICAL, GENERAL & PLASTIC SURGERY), HBE (DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)), HBB (MOTOR, DRILL, PNEUMATIC)

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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