Consulting Wallah › Device Explorer › Other devices › ENT trocar blade
Device Explorer · FDA GUDID · GMDN 33678

ENT trocar blade

A rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the int

US‑registered devices141in commercial distribution
Companies23labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Fentex Medical Gmbh3122%
Ambler Surgical Corp.1511%
Rz-Medizintechnik Gmbh129%
Karl Storz Gmbh & Co. Kg129%
Steris Corporation86%
Integra Lifesciences Production Corporation75%
Dufner - Instrumente Gmbh Fabrik Ärztlicher Instrumente Medizintechnik64%
Aesculap, Inc.64%

Top labelers

CompanyDevicesShare
Fentex Medical Gmbh3122%
Ambler Surgical Corp.1511%
Rz-Medizintechnik Gmbh129%
Karl Storz Gmbh & Co. Kg129%
Steris Corporation86%
Integra Lifesciences Production Corporation75%
Dufner - Instrumente Gmbh Fabrik Ärztlicher Instrumente Medizintechnik64%
Aesculap, Inc.64%
Spiggle & Theis Medizintechnik Gmbh54%
Evonos Gmbh & Co. Kg54%
Hnm Stainless, Llc.54%
Aesculap Ag43%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurtexBlades keyFENTEXAntrum trocar, oblique beakAntrum trocar, beakedDUFNER Instrumente GmbHevonosRZ Medizintechnik GmbHn.a.AESCULAPBOSS InstrumentsSymmetry SurgicalHNM MedicalNovo SurgicalN/AMarina Medical

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

FDA product codes

CodeNameDevices
LRCINSTRUMENT, ENT MANUAL SURGICAL48
KTETROCAR, ENT46
GCJLaparoscope, General & Plastic Surgery6
DRCTrocar6
JYTPick, Microsurgical Ear5
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE4

GMDN & GCC registration

  • GMDN code 33678 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 90% · 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) · 2Outer Diameter (Millimeter) · 1

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

How many ent trocar blade products are registered in the US?

141 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "ENT trocar blade", from 23 companies. The largest labeler is Fentex Medical Gmbh with 22% of records.

Which FDA product codes apply?

LRC (INSTRUMENT, ENT MANUAL SURGICAL), KTE (TROCAR, ENT), GCJ (Laparoscope, General & Plastic Surgery), DRC (Trocar)

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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