Device Explorer · FDA GUDID · GMDN 10696

Biliary drain

A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is dis

US‑registered devices570in commercial distribution
Companies17labelers on GUDID
Single‑use100%of device records
Sterile97%labelled sterile
Prescription85%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Micro-Tech (Nanjing) Co., Ltd.24142%
Cook Incorporated7714%
Boston Scientific Corporation6311%
Merit Medical Systems, Inc.387%
Fortune Medical Instrument Corp.346%
Bentec Medical Opco, Llc326%
Uresil, Llc275%
Lucas Medical Inc142%

Top labelers

CompanyDevicesShare
Micro-Tech (Nanjing) Co., Ltd.24142%
Cook Incorporated7714%
Boston Scientific Corporation6311%
Merit Medical Systems, Inc.387%
Fortune Medical Instrument Corp.346%
Bentec Medical Opco, Llc326%
Uresil, Llc275%
Lucas Medical Inc142%
Argon Medical Devices, Inc.81%
Mermaid Medical A/S81%
Edwards Lifesciences Llc61%
Applied Medical Resources Corporation61%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Biliary Plastic Stent SetBiliary Plastic StentBiliary Plastic Stent Set/ short-wire compatibleBiliary Plastic Stent Introducer/ short-wire comBiliary Plastic Stent IntroducerSilicone T Drainage SetSilicone T Drainage Set With EyesSilicone T Drainage TubeSilicone T Drainage Tube With EyesSkater™ Biliary Drainage Catheter Locking PigtaiSkater™ Biliary Drainage Catheter Non-Locking NSlater™Introducer Biliary Kit - LockingSkater™ Biliary Drainage Catheter Non-LockingReSolve®ReSolve®, Revolution™ReSolve®, StayFIX®

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 Ducts245
FGECatheter, Biliary, Diagnostic101
FGECATHETER, BILIARY, DIAGNOSTIC79
FGEStents, drains and dilators for the biliary ducts38
GCACatheter, Biliary, Surgical34
LJECATHETER, NEPHROSTOMY33

GMDN & GCC registration

  • GMDN code 10696 · implantable
  • Single‑use 100% · sterile 97% · Rx‑only 85% · 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 Diameter (Millimeter) · 233Stent Length (Millimeter) · 230Catheter Gauge (French) · 97Length (Centimeter) · 81Outer Diameter (Millimeter) · 11Shaft Length (Millimeter) · 4

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

No closely related category with 50+ devices.

How many biliary drain products are registered in the US?

570 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Biliary drain", from 17 companies. The largest labeler is Micro-Tech (Nanjing) Co., Ltd. with 42% of records.

Which FDA product codes apply?

FGE (Stents, Drains And Dilators For The Biliary Ducts), FGE (Catheter, Biliary, Diagnostic), 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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