Consulting Wallah › Device Explorer › Other devices › Metal/carbide ENT bur, reusable
Device Explorer · FDA GUDID · GMDN 46391

Metal/carbide ENT bur, reusable

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 devices121in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile7%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Bien-Air Surgery Sa6150%
Gyrus Acmi, Llc2621%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung2420%
Medtronic Xomed, Inc.87%
Integra Lifesciences Production Corporation22%

Top labelers

CompanyDevicesShare
Bien-Air Surgery Sa6150%
Gyrus Acmi, Llc2621%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung2420%
Medtronic Xomed, Inc.87%
Integra Lifesciences Production Corporation22%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

n/aGyrus ACMIGYRUS ACMIOto-FlexIntegra®HS Stand. Burr, Ø7.0x70, 50kHS Stand. Burr, Ø6.0x70, 50kHS Stand. Burr, Ø5.0x70, 50kHS Stand. Burr, Ø4.0x70, 50kHS Stand. Burr, Ø3.5x70, 50kHS Stand. Burr, Ø3.1x70, 50kHS Stand. Burr, Ø2.7x70, 50kHS Stand. Burr, Ø2.3x70, 50kHS Stand. Burr, Ø1.8x70, 50kHS Stand. Burr, Ø1.4x70, 50kHS Stand. Burr, Ø1.0x70, 50k

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 Throat61
EQJBUR, EAR, NOSE AND THROAT37
EJLBUR, DENTAL24
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP7

GMDN & GCC registration

  • GMDN code 46391 · non‑implantable
  • Single‑use 0% · sterile 7% · Rx‑only 100% · 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) · 11Length (Millimeter) · 2

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

How many metal/carbide ent bur, reusable products are registered in the US?

121 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Metal/carbide ENT bur, reusable", from 5 companies. The largest labeler is Bien-Air Surgery Sa with 50% of records.

Which FDA product codes apply?

EQJ (Bur, Ear, Nose And Throat), EQJ (BUR, EAR, NOSE AND THROAT), EJL (BUR, DENTAL), 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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