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Device Explorer · FDA GUDID · GMDN 53616

Bare-metal coronary artery stent

A non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic hear

US‑registered devices241in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biotronik Ag6226%
Abbott Vascular Inc.5724%
Boston Scientific Corporation4820%
Medinol Ltd.3715%
Celonova Biosciences, Inc.3012%
Tryton Medical, Inc.73%

Top labelers

CompanyDevicesShare
Biotronik Ag6226%
Abbott Vascular Inc.5724%
Boston Scientific Corporation4820%
Medinol Ltd.3715%
Celonova Biosciences, Inc.3012%
Tryton Medical, Inc.73%

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

Brand names on the register (sample)

NIRxcell™ CoCr Coronary Stent on RX SystemNIRxcell CoCr Coronary Stent on RX SystemTryton Side Branch StentCobra PzFGraftmasterMULTI-LINK VISIONMULTI-LINK MINI VISIONREBEL™PK PapyrusPRO-Kinetic Energy

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

FDA product codes

CodeNameDevices
MAFSTENT, CORONARY334
MAFStent, Coronary74
NIVcoronary covered stent32
DYGCATHETER, FLOW DIRECTED15

GMDN & GCC registration

  • GMDN code 53616 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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 (Millimeter) · 145Outer Diameter (Millimeter) · 37Lumen/Inner Diameter (Millimeter) · 30

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

How many bare-metal coronary artery stent products are registered in the US?

241 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bare-metal coronary artery stent", from 6 companies. The largest labeler is Biotronik Ag with 26% of records.

Which FDA product codes apply?

MAF (STENT, CORONARY), MAF (Stent, Coronary), NIV (coronary covered stent), DYG (CATHETER, FLOW DIRECTED)

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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