Consulting Wallah › Device Explorer › Cardiovascular › Polymeric tracheal/bronchial stent, non-bioabsorba
Device Explorer · FDA GUDID · GMDN 46977

Polymeric tracheal/bronchial stent, non-bioabsorbable

A non-bioabsorbable tubular device intended to be implanted into the trachea and/or a bronchus/bronchiole to maintain luminal patency, typically used in cases of obstructions/stenoses, fistulae, tumours, scarring, surgical resection and anastomosis, or pulmona

US‑registered devices774in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile29%labelled sterile
Prescription93%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Novatech67988%
Merit Medical Systems, Inc.9012%
Visionair Solutions, Llc51%

Top labelers

CompanyDevicesShare
Novatech67988%
Merit Medical Systems, Inc.9012%
Visionair Solutions, Llc51%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRACHEOBRONXANE™ DUMON™TRACHEOBRONXANE™ DUMON™ RADIO OPAQUEAEROmini®AERO®AERO DV®VisionAir Enhanced Stock StentVisionAir 3D StentTRACHEOBRONXANE™ DUMON® RADIOPAQUETRACHEOBRONXANE™ DUMON®

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

FDA product codes

CodeNameDevices
NWAProsthesis, Tracheal, Preformed/Molded758
JCTProsthesis, tracheal, expandable89
NYTProsthesis, tracheal, expandable, polymeric3
JCTProsthesis, Tracheal, Expandable1
OCYEndoscopic guidewire, gastroenterology-urology1

GMDN & GCC registration

  • GMDN code 46977 · implantable
  • Single‑use 100% · sterile 29% · Rx‑only 93% · 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

Stent Length (Millimeter) · 1Stent Diameter (Millimeter) · 1

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

How many polymeric tracheal/bronchial stent, non-bioabsorbable products are registered in the US?

774 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymeric tracheal/bronchial stent, non-bioabsorbable", from 3 companies. The largest labeler is Novatech with 88% of records.

Which FDA product codes apply?

NWA (Prosthesis, Tracheal, Preformed/Molded), JCT (Prosthesis, tracheal, expandable), NYT (Prosthesis, tracheal, expandable, polymeric), JCT (Prosthesis, Tracheal, Expandable)

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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