Consulting Wallah › Device Explorer › Procedure kits & trays › ENT surgical procedure kit, non-medicated, reusabl
Device Explorer · FDA GUDID · GMDN 44067

ENT surgical procedure kit, non-medicated, reusable

A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device.

US‑registered devices1,149in commercial distribution
Companies19labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Elmed Incorporated74265%
Avalign Technologies, Inc.23621%
National Advanced Endoscopy Devices, Inc.908%
Integra Lifesciences Production Corporation222%
Surgipros, Llc151%
Heinz Kurz Gmbh131%
Cochlear Limited71%
Advanced Bionics, Llc40%

Top labelers

CompanyDevicesShare
Elmed Incorporated74265%
Avalign Technologies, Inc.23621%
National Advanced Endoscopy Devices, Inc.908%
Integra Lifesciences Production Corporation222%
Surgipros, Llc151%
Heinz Kurz Gmbh131%
Cochlear Limited71%
Advanced Bionics, Llc40%
Br Surgical, Llc30%
Surgical Direct, Inc.30%
Carnegie Surgical Llc30%
Boston Medical Products, Inc.20%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Test Weight Set Upper Eyelid ImplantMontgomery® Thyroplasty Instrument SetNATULAAEDPROCEM PREPARATION STATIONNovo Surgical Inc.ELMEDELMED Version or Model Number:* 42-7010BR Surgical, LLCHiRes™ Ultra Reusable Surgical Tools KitHiRes™ Ultra Magnet Pusher ToolHiRes™ Ultra Magnet Tool KitHiRes™ Ultra Magnet Insertion ToolGyrus ACMISURGIPROS

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 Surgical886
LRCINSTRUMENT, ENT MANUAL SURGICAL94
KAEFORCEPS, ENT39
KAYPUNCH, NASAL30
GEIElectrosurgical, Cutting & Coagulation & Accessories18
OGREar, nose, and throat surgical tray17

GMDN & GCC registration

  • GMDN code 44067 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 88% · 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 (Millimeter) · 1Needle Gauge (Gauge) · 1Outer Diameter (Millimeter) · 1

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

How many ent surgical procedure kit, non-medicated, reusable products are registered in the US?

1,149 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "ENT surgical procedure kit, non-medicated, reusable", from 19 companies. The largest labeler is Elmed Incorporated with 65% of records.

Which FDA product codes apply?

LRC (Instrument, Ent Manual Surgical), LRC (INSTRUMENT, ENT MANUAL SURGICAL), KAE (FORCEPS, ENT), KAY (PUNCH, 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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