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Device Explorer · FDA GUDID · GMDN 14066

Tongue depressor, surgical

A hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or mor

US‑registered devices445in commercial distribution
Companies33labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Rz-Medizintechnik Gmbh6414%
Spiggle & Theis Medizintechnik Gmbh6214%
Sklar Corporation5913%
Aesculap Ag5111%
Fentex Medical Gmbh4711%
Avalign Technologies, Inc.164%
Integra Lifesciences Production Corporation143%
Medicon Eg. Chirurgiemechaniker-Genossenschaft123%

Top labelers

CompanyDevicesShare
Rz-Medizintechnik Gmbh6414%
Spiggle & Theis Medizintechnik Gmbh6214%
Sklar Corporation5913%
Aesculap Ag5111%
Fentex Medical Gmbh4711%
Avalign Technologies, Inc.164%
Integra Lifesciences Production Corporation143%
Medicon Eg. Chirurgiemechaniker-Genossenschaft123%
Integra Microfrance123%
Plasdent Corporation112%
Devemed Gmbh102%
Sontec Instruments, Inc.102%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DepressorsTongue bladeOrbita protectorRussel-Davis tongue depressorFENTEXDavis-Boyle tongue depressorMoritz-Schmidt tongue depressorHartmann tongue depressorFrenzel tongue depressorBuchwald tongue depressorBrünings tongue depressorDingmann tongue depressorHerberhold tongue depressorHerberhold tongue depressor, size 2Herberhold tongue depressor, size 1Ring tongue depressor, holder right side

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

FDA product codes

CodeNameDevices
KBLDEPRESSOR, METAL TONGUE, SURGICAL186
LRCINSTRUMENT, ENT MANUAL SURGICAL105
FMADEPRESSOR, TONGUE, NON-SURGICAL52
KALRETRACTOR, ENT19
KBLDepressor, Metal Tongue, Surgical17
NRDUnit, Operative Dental, Accessories11

GMDN & GCC registration

  • GMDN code 14066 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 80% · 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

Width (Millimeter) · 6Length (Inch) · 5Length (Millimeter) · 3

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

How many tongue depressor, surgical products are registered in the US?

445 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tongue depressor, surgical", from 33 companies. The largest labeler is Rz-Medizintechnik Gmbh with 14% of records.

Which FDA product codes apply?

KBL (DEPRESSOR, METAL TONGUE, SURGICAL), LRC (INSTRUMENT, ENT MANUAL SURGICAL), FMA (DEPRESSOR, TONGUE, NON-SURGICAL), KAL (RETRACTOR, ENT)

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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