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Device Explorer · FDA GUDID · GMDN 11339

Middle ear drill bit

A cylindrical shaft of metal with a small cutting head (e.g., twisted or helicoidal) which when rotated will bore into the tissues of the middle ear to excavate, perforate, or excise tissue (e.g., ossicles, cartilage) during a middle ear (endaural) surgical pr

US‑registered devices53in commercial distribution
Companies2labelers on GUDID
Single‑use96%of device records
Sterile98%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Bien-Air Surgery Sa5298%
Gyrus Acmi, Llc12%

Top labelers

CompanyDevicesShare
Bien-Air Surgery Sa5298%
Gyrus Acmi, Llc12%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Gyrus ACMIDia.Perf.Mic-Ear-Bur,Ø0.35,12kDiam. Micro-Ear-Burr,Ø2.3,12kDiam. Micro-Ear-Burr,Ø1.8,12kDiam. Micro-Ear-Burr,Ø1.4,12kDiam. Micro-Ear-Burr,Ø1.2,12kDiam. Micro-Ear-Burr,Ø1.0,12kDiam. Micro-Ear-Burr,Ø0.8,12kDiam. Micro-Ear-Burr,Ø0.7,12kDiam. Micro-Ear-Burr,Ø0.6,12kT.Carb.Micro-Ear-Burr,Ø2.3,12kT.Carb.Micro-Ear-Burr,Ø1.8,12kT.Carb.Micro-Ear-Burr,Ø1.4,12kT.Carb.Micro-Ear-Burr,Ø1.0,12kT.Carb.Micro-Ear-Burr,Ø0.8,12kT.Carb.Micro-Ear-Burr,Ø0.7,12k

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 Throat52
NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed51
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handp51
LRCINSTRUMENT, ENT MANUAL SURGICAL1

GMDN & GCC registration

  • GMDN code 11339 · non‑implantable
  • Single‑use 96% · sterile 98% · 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

No structured size data on the register.

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

How many middle ear drill bit products are registered in the US?

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Middle ear drill bit", from 2 companies. The largest labeler is Bien-Air Surgery Sa with 98% of records.

Which FDA product codes apply?

EQJ (Bur, Ear, Nose And Throat), NLY (Microdebrider, Ent, High Speed, Single Use, Reprocessed), ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handp), LRC (INSTRUMENT, ENT MANUAL SURGICAL)

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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