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Device Explorer · FDA GUDID · GMDN 43691

Bare-metal biliary stent

A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely o

US‑registered devices1,114in commercial distribution
Companies14labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Bard Peripheral Vascular, Inc.26924%
Cordis Us Corp.21319%
Covidien Lp16315%
Cook Incorporated969%
M.I.Tech Co., Ltd.868%
Cook Ireland Ltd757%
Taewoongmedical.Co.,Ltd646%
Cordis Corporation494%

Top labelers

CompanyDevicesShare
Bard Peripheral Vascular, Inc.26924%
Cordis Us Corp.21319%
Covidien Lp16315%
Cook Incorporated969%
M.I.Tech Co., Ltd.868%
Cook Ireland Ltd757%
Taewoongmedical.Co.,Ltd646%
Cordis Corporation494%
Boston Scientific Corporation484%
Ev3, Inc242%
Sewoon Medical Co., Ltd.121%
Medinol Ltd.81%

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

Brand names on the register (sample)

X-SUIT NIR BILIARY METALLIC STENTE·Luminexx® Biliary StentE-Luminexx® Vascular & Biliary StentLifeStent® XL Vascular & Biliary Stent SystemLifeStent® Vascular & Biliary Stent SystemLifeStar® Biliary StentLifeStar® Vascular & Biliary StentLifeStent® XL Vascular & Biliary StentLifeStent® Vascular & Biliary StentLifeStent® Biliary StentALIMAXX-B®Protégé™ GPS™Protégé EverFlex™Protege EverFlexVisi-ProProtege RX

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

FDA product codes

CodeNameDevices
FGECATHETER, BILIARY, DIAGNOSTIC910
NIOSTENT, ILIAC106
FGECatheter, Biliary, Diagnostic102
NIPSTENT, SUPERFICIAL FEMORAL ARTERY84
FGEStents, drains and dilators for the biliary ducts83
FGEStents, Drains And Dilators For The Biliary Ducts71

GMDN & GCC registration

  • GMDN code 43691 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · 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) · 286Outer Diameter (Millimeter) · 218Catheter Gauge (French) · 210Stent Diameter (Millimeter) · 86Stent Length (Millimeter) · 86Catheter Working Length (Centimeter) · 32

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

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

1,114 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bare-metal biliary stent", from 14 companies. The largest labeler is Bard Peripheral Vascular, Inc. with 24% of records.

Which FDA product codes apply?

FGE (CATHETER, BILIARY, DIAGNOSTIC), NIO (STENT, ILIAC), FGE (Catheter, Biliary, Diagnostic), NIP (STENT, SUPERFICIAL FEMORAL ARTERY)

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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