Consulting Wallah › Device Explorer › Cardiovascular › Polymeric biliary stent, non-bioabsorbable
Device Explorer · FDA GUDID · GMDN 43764

Polymeric biliary stent, non-bioabsorbable

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), sili

US‑registered devices1,027in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Cook Ireland Ltd38437%
Medi-Globe Gmbh31731%
Olympus Medical Systems Corp.17617%
Boston Scientific Corporation12712%
Merit Medical Systems, Inc.91%
Hobbs Medical, Inc.81%
Endo Gi Medical Ltd61%

Top labelers

CompanyDevicesShare
Cook Ireland Ltd38437%
Medi-Globe Gmbh31731%
Olympus Medical Systems Corp.17617%
Boston Scientific Corporation12712%
Merit Medical Systems, Inc.91%
Hobbs Medical, Inc.81%
Endo Gi Medical Ltd61%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Single Use Biliary Drainage Stent VBiliary Drainage TubeEndoflux™ReSolve ConvertX®EndoGI Specialized S-Path Delivery SystemS-Path Biliary Stent System (140mm)S-Path Pre-loaded RX Biliary Stent System (80mm)S-Path Pre-loaded RX Biliary Stent SystemX-Path Pre-loaded RX-OTW Double Biliary Stents SCompass BDSFusion MarathonCotton-LeungSoehendra TannenbaumCotton-HuibregtseOasisZimmon

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, DIAGNOSTIC864
FGEStents, Drains And Dilators For The Biliary Ducts366
FGECatheter, Biliary, Diagnostic16
FGEStents, drains and dilators for the biliary ducts12

GMDN & GCC registration

  • GMDN code 43764 · 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

Stent Length (Millimeter) · 4

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

How many polymeric biliary stent, non-bioabsorbable products are registered in the US?

1,027 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymeric biliary stent, non-bioabsorbable", from 7 companies. The largest labeler is Cook Ireland Ltd with 37% of records.

Which FDA product codes apply?

FGE (CATHETER, BILIARY, DIAGNOSTIC), FGE (Stents, Drains And Dilators For The Biliary Ducts), 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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