Home GUDID 00860005738250
EndoGI Specialized S-Path Delivery System
Primary DI 00860005738250
Brand EndoGI Specialized S-Path Delivery System
Company ENDO GI MEDICAL LTD
Model Delivery System
Device description The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures.The EndoGI S-Path Delivery System enables insertion and placement of one stent in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site.The EndoGI Specialized S-Path Biliary Delivery System is to be loaded with a compatible pigtail stent prior to use. The system is compatible with a 10Fr (2.4 mm inner diameter and 3.4mm outer diameter) pigtail stent with a length of 7 cm (total length up to 20 cm).
Published 2025-04-07
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
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 10860005738257 Package GS1 10 In Commercial Distribution 00860005738250 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 10860005738257 10860005738257 00860005738250 00860005738250 860005738250 0860005738250
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.
Regulatory Flags# DUNS number 532316194 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 10860005738219 S-Path Pre-loaded RX Biliary Stent System Single-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