X-Path Pre-loaded RX-OTW Double Biliary Stents System - The EndoGI X-Path Pre-loaded RX-OTW Double - ENDO GI MEDICAL LTD

Duns Number:532316194

Device Description: The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deplo 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.

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More Product Details

Catalog Number

-

Brand Name

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

Version/Model Number

Double-Stent

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K193600,K193600

Product Code Details

Product Code

FGE

Product Code Name

Stents, Drains And Dilators For The Biliary Ducts

Device Record Status

Public Device Record Key

10bd00aa-9fa2-48cd-8782-3a7c3da49724

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Additional Identifiers

Package DI Number

10860005738202

Quantity per Package

10

Contains DI Package

00860005738205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ENDO GI MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1