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Device Explorer · FDA GUDID · GMDN 35085

Mouth gag, adjustable, reusable

A mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention.

US‑registered devices1,098in commercial distribution
Companies56labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Integra Lifesciences Production Corporation12712%
Medicon Eg. Chirurgiemechaniker-Genossenschaft737%
Surtex Instruments Ltd.706%
Avalign Technologies, Inc.686%
Kls-Martin L.P.666%
Ambler Surgical Corp.666%
Fentex Medical Gmbh464%
Novo Surgical, Inc.394%

Top labelers

CompanyDevicesShare
Integra Lifesciences Production Corporation12712%
Medicon Eg. Chirurgiemechaniker-Genossenschaft737%
Surtex Instruments Ltd.706%
Avalign Technologies, Inc.686%
Kls-Martin L.P.666%
Ambler Surgical Corp.666%
Fentex Medical Gmbh464%
Novo Surgical, Inc.394%
Sklar Corporation394%
Hnm Stainless, Llc.363%
Evonos Gmbh & Co. Kg313%
Steris Corporation313%

Company = labeler of record on GUDID. 56 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurtexNABMT Medizintechnik GmbHDehnhardt mouth gagMolt mouth gagMcIvor mouth gagDavis-Boyle mouth gagRoser-König mouth gagPalate plateFENTEXJennings mouth gagSeemann-Seiffert mouth gagDingmann teeth hooks, movableDingmann mouth gag, frame withMcIvor mouth gag, wire frame withDavis-Meyer mouth gag, left side open

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

FDA product codes

CodeNameDevices
KBNGAG, MOUTH600
LRCINSTRUMENT, ENT MANUAL SURGICAL177
KBNGag, Mouth157
LRCInstrument, Ent Manual Surgical53
EIGRETRACTOR, ALL TYPES42
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY25

GMDN & GCC registration

  • GMDN code 35085 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 76% · 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) · 29Length (Millimeter) · 26Length (Inch) · 6Depth (Millimeter) · 3Width (Inch) · 2Length (Centimeter) · 1

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

How many mouth gag, adjustable, reusable products are registered in the US?

1,098 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mouth gag, adjustable, reusable", from 56 companies. The largest labeler is Integra Lifesciences Production Corporation with 12% of records.

Which FDA product codes apply?

KBN (GAG, MOUTH), LRC (INSTRUMENT, ENT MANUAL SURGICAL), KBN (Gag, Mouth), LRC (Instrument, Ent Manual Surgical)

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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