X-Path Pre-loaded RX-OTW Double Biliary Stents System

GUDID 00860005738205

The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) 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 Delivery System enables insertion and placement of two stents 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 Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.

ENDO GI MEDICAL LTD

Polymeric biliary stent, non-bioabsorbable

• Primary Device ID: 00860005738205
• NIH Device Record Key: 10bd00aa-9fa2-48cd-8782-3a7c3da49724
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Path Pre-loaded RX-OTW Double Biliary Stents System
• Version Model Number: Double-Stent
• Company DUNS: 532316194
• Company Name: ENDO GI MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com
• Phone: +97246098600
• Email: omri@EndogI-Medical.com

Device Dimensions

• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter
• Stent Length: 110 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005738205 [Primary]
GS1	10860005738202 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193600

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-09
• Device Publish Date: 2020-12-01

Devices Manufactured by ENDO GI MEDICAL LTD

• 00860005738229 - S-Path Pre-loaded RX Biliary Stent System (80mm): 2023-09-05 The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainag
• 00860005738236 - S-Path Biliary Stent System (140mm): 2023-09-05 The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainag
• 00860005738205 - X-Path Pre-loaded RX-OTW Double Biliary Stents System: 2020-12-09The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) 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 Delivery System enables insertion and placement of two stents 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 Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.
• 00860005738205 - X-Path Pre-loaded RX-OTW Double Biliary Stents System: 2020-12-09 The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) e
• 10860005738219 - S-Path Pre-loaded RX Biliary Stent System: 2020-12-09 The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainag