Home GUDID 10860005738219
S-Path Pre-loaded RX Biliary Stent System
Primary DI 10860005738219
Brand S-Path Pre-loaded RX Biliary Stent System
Company ENDO GI MEDICAL LTD
Model Single-Stent
Device description The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 110 mm stent preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.
Published 2020-12-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name FGE Stents, Drains And Dilators For The Biliary Ducts
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860005738219 Package GS1 10 In Commercial Distribution 00860005738212 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10860005738219 10860005738219 00860005738212 00860005738212 860005738212 0860005738212
GMDN Terms# Term, Definition table Term Definition 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), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Stent Length 110 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 532316194 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860005738250 EndoGI Specialized S-Path Delivery System Delivery System 2025-04-07 00860005738243 EndoGI Specialized S-Path Delivery System Delivery System 2025-03-21 00860005738229 S-Path Pre-loaded RX Biliary Stent System (80mm) Single-Stent (80mm) 2023-08-28 00860005738236 S-Path Biliary Stent System (140mm) Single-Stent (140mm) 2023-08-28 00860005738212 S-Path Pre-loaded RX Biliary Stent System Single-Stent 2020-12-01 00860005738205 X-Path Pre-loaded RX-OTW Double Biliary Stents System Double-Stent 2020-12-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06959664925645 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-06-18 06959664925676 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-06-18 06959664925584 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664925614 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664925959 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664925980 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926017 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926048 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926314 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926345 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926376 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926406 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926673 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926703 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926734 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664926765 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927038 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927069 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927090 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927120 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927403 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927434 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927465 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664927496 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664928943 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664928974 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664929001 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664929032 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664929070 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15 06959664929100 NA Hangzhou AGS MedTech Co., Ltd. FGE 2026-04-15