Consulting Wallah › Device Explorer › Other devices › Intranasal splint, biodegradable
Device Explorer · FDA GUDID · GMDN 41493

Intranasal splint, biodegradable

A bioabsorbable device intended to be placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the

US‑registered devices57in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medifab Co., Ltd3765%
Stryker Corporation916%
Spirair, Inc.47%
3-D Matrix Inc.35%
Smith & Nephew, Inc.35%
Chitogel Limited12%

Top labelers

CompanyDevicesShare
Medifab Co., Ltd3765%
Stryker Corporation916%
Spirair, Inc.47%
3-D Matrix Inc.35%
Smith & Nephew, Inc.35%
Chitogel Limited12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NasoporeTurbAlignPuraSinus 1mLPuraSinus 3mLPuraSinus 5mLENT SinusEndoscopic Sinus Surgery KitHusteon MeshNasalHusteon Nasal

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

FDA product codes

CodeNameDevices
LYASplint, Intranasal Septal43
LYASPLINT, INTRANASAL SEPTAL11
EMXBalloon, Epistaxis6
NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable3
OLLSeptal Stapler/Absorbable staples2
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)2

GMDN & GCC registration

  • GMDN code 41493 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 98% · 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 (Centimeter) · 7

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How many intranasal splint, biodegradable products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intranasal splint, biodegradable", from 6 companies. The largest labeler is Medifab Co., Ltd with 65% of records.

Which FDA product codes apply?

LYA (Splint, Intranasal Septal), LYA (SPLINT, INTRANASAL SEPTAL), EMX (Balloon, Epistaxis), NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable)

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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