Consulting Wallah › Device Explorer › Other devices › Metal/carbide ENT bur, single-use
Device Explorer · FDA GUDID · GMDN 34848

Metal/carbide ENT bur, single-use

A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. I

US‑registered devices565in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile84%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Bien-Air Surgery Sa17331%
Gyrus Acmi, Llc12823%
Medtronic Xomed, Inc.9717%
Jedmed Instrument Company8816%
Invotec International, Inc.285%
Eon Meditech Private Limited285%
Grace Medical, Inc.132%
Acclarent, Inc.102%

Top labelers

CompanyDevicesShare
Bien-Air Surgery Sa17331%
Gyrus Acmi, Llc12823%
Medtronic Xomed, Inc.9717%
Jedmed Instrument Company8816%
Invotec International, Inc.285%
Eon Meditech Private Limited285%
Grace Medical, Inc.132%
Acclarent, Inc.102%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ViSAO®DragonFly™ BUR, CTR, EGG, 80MM L, 2.3MM Ø, BurShDragonFly™ BUR, CTR, RD, 80MM L, 0.4MM Ø, BurShiDragonFly™ BUR, CTR, CYL, 80MM L, 1.8MM Ø, BurShDragonFly™ BUR, CTR, RD, 80MM L, 2.3MM Ø, BurShiDragonFly™ BUR, CTR, RD, 80MM L, 1.8MM Ø, BurShiDragonFly™ BUR, CTR, RD, 80MM L, 1.4MM Ø, BurShiDragonFly™ BUR, CTR, RD, 80MM L, 0.8MM Ø, BurShiDragonFly™ BUR, CTR, RD, 80MM L, 0.7MM Ø, BurShiDragonFly™ BUR, CTR, RD, 80MM L, 0.6MM Ø, BurShiDragonFly™ BUR, CTR, RD, 80MM L, 0.5MM Ø, BurShiDragonFly™ BUR, TROCAR PERF, 95MM L, 0.35MM ØDragonFly™ BUR, CTR, EGG, 80MM L, 1.8MM Ø, BurShDragonFly™ BUR, CTR, RD, 80MM L, 1.0MM Ø, BurShiDIEGO ELITEGyrus ACMI

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 Throat360
EQJBUR, EAR, NOSE AND THROAT205
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)185
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handp160
NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed158
HBCMotor, Drill, Electric156

GMDN & GCC registration

  • GMDN code 34848 · non‑implantable
  • Single‑use 100% · sterile 84% · 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) · 115Angle (degree) · 55Length (Millimeter) · 52Length (Centimeter) · 46Outer Diameter (Centimeter) · 1

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

How many metal/carbide ent bur, single-use products are registered in the US?

565 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Metal/carbide ENT bur, single-use", from 8 companies. The largest labeler is Bien-Air Surgery Sa with 31% of records.

Which FDA product codes apply?

EQJ (Bur, Ear, Nose And Throat), EQJ (BUR, EAR, NOSE AND THROAT), HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handp)

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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