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Device Explorer · FDA GUDID · GMDN 45527

Diamond ENT bur, single-use

A rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an

US‑registered devices574in commercial distribution
Companies11labelers on GUDID
Single‑use100%of device records
Sterile95%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Bien-Air Surgery Sa25444%
Gyrus Acmi, Llc10518%
Wexler Surgical, Inc.549%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung295%
Grace Medical, Inc.244%
Medtronic Xomed, Inc.244%
Invotec International, Inc.224%
Eon Meditech Private Limited224%

Top labelers

CompanyDevicesShare
Bien-Air Surgery Sa25444%
Gyrus Acmi, Llc10518%
Wexler Surgical, Inc.549%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung295%
Grace Medical, Inc.244%
Medtronic Xomed, Inc.244%
Invotec International, Inc.224%
Eon Meditech Private Limited224%
Stryker Corporation203%
Karl Storz Gmbh & Co. Kg122%
Omega Surgical Instruments Inc81%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PELLONAn.a.n/aDragonFly™ Skinny BUR, 100MM x 1.4MMDragonFly™ Skinny BUR, 100MM x 1.0MMDragonFly™ Skinny BUR, 100MM x 0.8MMDragonFly™ Skinny BUR, 100MM x 0.7MMDragonFly™ Skinny BUR, 100MM x 0.6MMDragonFly™ Skinny BUR,100MM x 0.5MMDragonFly™ BUR, DMD, RD, 120MM L, 1.0MM ØDragonFly™ BUR, DMD, RD, 120MM L, 0.7MM ØDragonFly™ BUR, DMD, RD, 100MM L, 1.4MM Ø, RWDragonFly™ BUR, DMD, RD, 100MM L, 1.0MM Ø, RWDragonFly™ BUR,DMD,RD,100MM L, 0.7MM Ø, RWDragonFly™ BUR, DMD, RD, 95MM L, 2.3MM Ø, BurShi

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

FDA product codes

CodeNameDevices
EQJBur, Ear, Nose And Throat424
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)251
HBCMotor, Drill, Electric233
NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed233
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handp232
EQJBUR, EAR, NOSE AND THROAT174

GMDN & GCC registration

  • GMDN code 45527 · non‑implantable
  • Single‑use 100% · sterile 95% · Rx‑only 88% · 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) · 44Angle (degree) · 22Length (Millimeter) · 22Length (Centimeter) · 17

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

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

574 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Diamond ENT bur, single-use", from 11 companies. The largest labeler is Bien-Air Surgery Sa with 44% of records.

Which FDA product codes apply?

EQJ (Bur, Ear, Nose And Throat), HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), HBC (Motor, Drill, Electric), NLY (Microdebrider, Ent, High Speed, Single Use, Reprocessed)

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.

How do I get quotes?

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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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