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Device Explorer · FDA GUDID · GMDN 33442

Craniofacial rongeur, reusable

A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectom

US‑registered devices1,931in commercial distribution
Companies43labelers on GUDID
Single‑use19%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Koros U.S.A., Inc.44423%
Novo Surgical, Inc.38220%
Aesculap Ag19910%
Ebner Medical, Llc1659%
Integra Lifesciences Production Corporation1508%
Elmed Incorporated945%
Sontec Instruments, Inc.573%
Integra Microfrance523%

Top labelers

CompanyDevicesShare
Koros U.S.A., Inc.44423%
Novo Surgical, Inc.38220%
Aesculap Ag19910%
Ebner Medical, Llc1659%
Integra Lifesciences Production Corporation1508%
Elmed Incorporated945%
Sontec Instruments, Inc.573%
Integra Microfrance523%
Avalign Technologies, Inc.422%
Bear-Ent, Llc392%
Kls-Martin L.P.382%
Hnm Stainless, Llc.221%

Company = labeler of record on GUDID. 43 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

KamiyamaKerrison rongeurFENTEXRowland rongeurKazanjian rongeurCitelli rongeurevonosN.A.GimmiAESCULAPMediconBOSS InstrumentsRONGEURFORCEPSHNM MEDICALHNM Medical

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

FDA product codes

CodeNameDevices
HTXRongeur1,077
HTXRONGEUR336
KAEFORCEPS, ENT148
KBBRONGEUR, NASAL92
KAXPunch, Ethmoid73
KBBRongeur, Nasal59

GMDN & GCC registration

  • GMDN code 33442 · non‑implantable
  • Single‑use 19% · sterile 0% · Rx‑only 96% · 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

Length (Inch) · 218Width (Millimeter) · 167Length (Centimeter) · 17Length (Millimeter) · 12Outer Diameter (Millimeter) · 2Width (Centimeter) · 2

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

How many craniofacial rongeur, reusable products are registered in the US?

1,931 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Craniofacial rongeur, reusable", from 43 companies. The largest labeler is Koros U.S.A., Inc. with 23% of records.

Which FDA product codes apply?

HTX (Rongeur), HTX (RONGEUR), KAE (FORCEPS, ENT), KBB (RONGEUR, NASAL)

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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