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Device Explorer · FDA GUDID · GMDN 35350

Nasal speculum, reusable

A hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of

US‑registered devices1,624in commercial distribution
Companies66labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Rz-Medizintechnik Gmbh1107%
Integra Lifesciences Production Corporation1107%
Ambler Surgical Corp.936%
Avalign Technologies, Inc.916%
Karl Storz Gmbh & Co. Kg805%
Spiggle & Theis Medizintechnik Gmbh684%
Fentex Medical Gmbh684%
Sklar Corporation674%

Top labelers

CompanyDevicesShare
Rz-Medizintechnik Gmbh1107%
Integra Lifesciences Production Corporation1107%
Ambler Surgical Corp.936%
Avalign Technologies, Inc.916%
Karl Storz Gmbh & Co. Kg805%
Spiggle & Theis Medizintechnik Gmbh684%
Fentex Medical Gmbh684%
Sklar Corporation674%
Surgical Direct, Inc.644%
Evonos Gmbh & Co. Kg594%
Med Saver, Inc.563%
Medicon Eg. Chirurgiemechaniker-Genossenschaft553%

Company = labeler of record on GUDID. 66 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

STILLE RetractorsSurtexThudichum nasal speculumNasal speculum type ViennaKillian septum speculumSelfholding SpekulumSinus speculum for adultsSinus speculum for childrenBrusis nasal speculumKillian-Struycken septum speculumCottle septum speculumHerberhold septum speculumHartmann-Halle nasal speculumHartmann nasal speculumLAZICFENTEX

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

FDA product codes

CodeNameDevices
EPYSPECULUM, ENT1,053
EPYSpeculum, Ent327
LRCINSTRUMENT, ENT MANUAL SURGICAL95
EIGRETRACTOR, ALL TYPES51
HDFSPECULUM, VAGINAL, METAL21
KAGHolder, Speculum, Ent18

GMDN & GCC registration

  • GMDN code 35350 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 70% · 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) · 51Length (Centimeter) · 37Length (Millimeter) · 14Depth (Millimeter) · 3Width (Millimeter) · 1Angle (degree) · 1

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

How many nasal speculum, reusable products are registered in the US?

1,624 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nasal speculum, reusable", from 66 companies. The largest labeler is Rz-Medizintechnik Gmbh with 7% of records.

Which FDA product codes apply?

EPY (SPECULUM, ENT), EPY (Speculum, Ent), LRC (INSTRUMENT, ENT MANUAL SURGICAL), EIG (RETRACTOR, ALL TYPES)

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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