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Device Explorer · FDA GUDID · GMDN 13418

Neurosurgical rongeur

A hand-held manual surgical instrument designed with a cutting/biting action used for the removal of bone, e.g., pieces of the skull, during a neurosurgical intervention. It is a strongly constructed instrument that has a forceps or pliers-like design terminat

US‑registered devices321in commercial distribution
Companies2labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Avalign Technologies, Inc.28589%
Sklar Corporation3611%

Top labelers

CompanyDevicesShare
Avalign Technologies, Inc.28589%
Sklar Corporation3611%

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

Brand names on the register (sample)

AvalignMillenniumPillingIMSSklar

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

FDA product codes

CodeNameDevices
HAERongeur, Manual187
HAERONGEUR, MANUAL98
HTXRONGEUR36

GMDN & GCC registration

  • GMDN code 13418 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 89% · 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) · 43Width (Millimeter) · 39Angle (degree) · 11Length (Millimeter) · 5Width (Inch) · 1

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

How many neurosurgical rongeur products are registered in the US?

321 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Neurosurgical rongeur", from 2 companies. The largest labeler is Avalign Technologies, Inc. with 89% of records.

Which FDA product codes apply?

HAE (Rongeur, Manual), HAE (RONGEUR, MANUAL), HTX (RONGEUR)

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.

How do I get quotes?

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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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