Device Explorer · FDA GUDID · GMDN 10828

Nasal chisel

A single-bladed, surgical instrument, bevelled on one side that is used to cut and shape the nasal bones during ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the

US‑registered devices519in commercial distribution
Companies29labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Fentex Medical Gmbh9218%
W.H. Holden, Inc.6813%
Rz-Medizintechnik Gmbh5711%
Ambler Surgical Corp.438%
Novo Surgical, Inc.387%
Evonos Gmbh & Co. Kg377%
Medicon Eg. Chirurgiemechaniker-Genossenschaft336%
Sklar Corporation245%

Top labelers

CompanyDevicesShare
Fentex Medical Gmbh9218%
W.H. Holden, Inc.6813%
Rz-Medizintechnik Gmbh5711%
Ambler Surgical Corp.438%
Novo Surgical, Inc.387%
Evonos Gmbh & Co. Kg377%
Medicon Eg. Chirurgiemechaniker-Genossenschaft336%
Sklar Corporation245%
Spiggle & Theis Medizintechnik Gmbh224%
Integra Lifesciences Production Corporation173%
Hayden Medical, Inc.122%
Avalign Technologies, Inc.92%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Cottle chiselChiselLAZICFENTEXCottle chisel, flat, with crossbarWest chiselevonosRZ Medizintechnik GmbHGimmin.a.AESCULAPMedicon"BONE CHISEL 4MM, 6"" S/E""BONE CHISEL 2.5MM, 6"" S/E"GOUGE 8mm CH S/EGOUGE 8mm BAYONET CH S/E

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

FDA product codes

CodeNameDevices
KANCHISEL, NASAL129
LRCINSTRUMENT, ENT MANUAL SURGICAL108
FZOCHISEL, SURGICAL, MANUAL96
EMMCHISEL, OSTEOTOME, SURGICAL80
HWMOSTEOTOME30
FZOChisel, Surgical, Manual28

GMDN & GCC registration

  • GMDN code 10828 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 71% · 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

Width (Millimeter) · 3Length (Inch) · 1

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

How many nasal chisel products are registered in the US?

519 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nasal chisel", from 29 companies. The largest labeler is Fentex Medical Gmbh with 18% of records.

Which FDA product codes apply?

KAN (CHISEL, NASAL), LRC (INSTRUMENT, ENT MANUAL SURGICAL), FZO (CHISEL, SURGICAL, MANUAL), EMM (CHISEL, OSTEOTOME, 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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