Consulting Wallah › Device Explorer › Cardiovascular › Polymeric biliary/pancreatic stent
Device Explorer · FDA GUDID · GMDN 63968

Polymeric biliary/pancreatic stent

A sterile bioabsorbable tubular device intended to be implanted in an obstructed/stenosed biliary and pancreatic duct (i.e., a dual-purpose device capable of implantation at either anatomy) to temporarily maintain luminal patency. It is in the form of a non-ex

US‑registered devices50in commercial distribution
Companies1labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Q3 Medical Usa Llc50100%

Top labelers

CompanyDevicesShare
Q3 Medical Usa Llc50100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ARCHIMEDES Biodegradable StentArchimedes Biodegradable Pancreatic Stent

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

FDA product codes

CodeNameDevices
FGEStents, Drains And Dilators For The Biliary Ducts50

GMDN & GCC registration

  • GMDN code 63968 · 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

No structured size data on the register.

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

How many polymeric biliary/pancreatic stent products are registered in the US?

50 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymeric biliary/pancreatic stent", from 1 companies. The largest labeler is Q3 Medical Usa Llc with 100% of records.

Which FDA product codes apply?

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.

How do I get quotes?

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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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