Consulting Wallah › Device Explorer › Other devices › Paranasal sinus trephine
Device Explorer · FDA GUDID · GMDN 38440

Paranasal sinus trephine

An ear/nose/throat (ENT) surgical blade designed to cut and remove circular sections of bone or mucous membrane from the paranasal sinuses. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may

US‑registered devices78in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Osstem Implant Co., Ltd.5874%
Ambler Surgical Corp.1621%
Hnm Stainless, Llc.34%
Société Chirurgicale Instrumentarium Inc11%

Top labelers

CompanyDevicesShare
Osstem Implant Co., Ltd.5874%
Ambler Surgical Corp.1621%
Hnm Stainless, Llc.34%
Société Chirurgicale Instrumentarium Inc11%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HNM MEDICALInstrumentariumAmbler SurgicalBone ProfilerOneGuide Bone Profiler

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

FDA product codes

CodeNameDevices
DZADrill, Dental, Intraoral58
LRYPUNCH, SURGICAL16
HWKTrephine3
KBFTrephine, Sinus1

GMDN & GCC registration

  • GMDN code 38440 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 95% · 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 paranasal sinus trephine products are registered in the US?

78 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Paranasal sinus trephine", from 4 companies. The largest labeler is Osstem Implant Co., Ltd. with 74% of records.

Which FDA product codes apply?

DZA (Drill, Dental, Intraoral), LRY (PUNCH, SURGICAL), HWK (Trephine), KBF (Trephine, Sinus)

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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