Consulting Wallah › Device Explorer › Cardiovascular › Peripheral artery stent, bare-metal
Device Explorer · FDA GUDID · GMDN 47932

Peripheral artery stent, bare-metal

A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or follo

US‑registered devices1,290in commercial distribution
Companies14labelers on GUDID
Single‑use100%of device records
Sterile97%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Abbott Vascular Inc.19815%
Biotronik Ag18714%
Covidien Lp18214%
Cook Ireland Ltd17914%
Bard Peripheral Vascular, Inc.14611%
Ev3, Inc1028%
Boston Scientific Corporation967%
Cordis Us Corp.675%

Top labelers

CompanyDevicesShare
Abbott Vascular Inc.19815%
Biotronik Ag18714%
Covidien Lp18214%
Cook Ireland Ltd17914%
Bard Peripheral Vascular, Inc.14611%
Ev3, Inc1028%
Boston Scientific Corporation967%
Cordis Us Corp.675%
Medtronic, Inc.353%
Terumo Corporation322%
Veryan Medical Limited292%
Cook Incorporated242%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BioMimics 3D Vascular Stent SystemR2P MISAGOMisago®LifeStent® XL Vascular Stent SystemE-Luminexx® Vascular & Biliary StentLifeStar® Vascular & Biliary StentLifeStent® Solo Vascular StentLifeStent® XL Vascular & Biliary StentLifeStent® Vascular & Biliary StentLifeStent® XL Vascular StentSpur Peripheral Retrievable Stent SystemZilver FlexProtégé™ GPS™EverFlexEverFlex™ Protégé™ EverFlex™EverFlex™

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

FDA product codes

CodeNameDevices
NIPSTENT, SUPERFICIAL FEMORAL ARTERY860
NIOSTENT, ILIAC480
FGECATHETER, BILIARY, DIAGNOSTIC119
FGEStents, drains and dilators for the biliary ducts110
NINSTENT, RENAL96
NIPStent, Superficial Femoral Artery78

GMDN & GCC registration

  • GMDN code 47932 · implantable
  • Single‑use 100% · sterile 97% · 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) · 519Catheter Gauge (French) · 409Outer Diameter (Millimeter) · 157Lumen/Inner Diameter (Millimeter) · 64Stent Diameter (Millimeter) · 44Stent Length (Millimeter) · 44

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

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

1,290 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Peripheral artery stent, bare-metal", from 14 companies. The largest labeler is Abbott Vascular Inc. with 15% of records.

Which FDA product codes apply?

NIP (STENT, SUPERFICIAL FEMORAL ARTERY), NIO (STENT, ILIAC), FGE (CATHETER, BILIARY, DIAGNOSTIC), FGE (Stents, drains and dilators for the biliary ducts)

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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