Niti-S Biliary Stent TD0807

GUDID 08809233100455

The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree. The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the biliary system. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the biliary system to establish and maintain patency. The stent is available in two diameters (8, 10mm), and eight lengths (40, 50, 60, 70, 80, 90, 100, 120mm). The stent has 10 radiopaque markers. There are two different types of introducers; percutaneous or endoscopic. They consists of an Inner Catheter, Outer Sheath, Hub, Y-connector, Tip and Pusher. All of the components of the introducers are supplied sterile in a disposable package. The Percutaneous type introducer is used when the site is accessed percutaneously and requires a guidewire (not included) to be advanced across the targeted stricture under fluoroscopy. The Endoscopic type introducer is for use in endoscopic procedures where the stent and introducer are inserted through the channel of an endoscope. The usable lengths of Percutaneous type introducer is 50cm and Endoscopic type introducer 180cm. Other information: The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.035 inch (0.89mm). Do not use if package is damaged. Do not reuse or resterilize.

TAEWOONGMEDICAL.CO.,LTD

Bare-metal biliary stent
Primary Device ID08809233100455
NIH Device Record Keyfb8dac84-6cb1-40b2-8c8e-91abc2c43951
Commercial Distribution StatusIn Commercial Distribution
Brand NameNiti-S Biliary Stent
Version Model NumberTD0807
Catalog NumberTD0807
Company DUNS689484322
Company NameTAEWOONGMEDICAL.CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net
Phone+82319960641
Emailsales@stent.net

Device Dimensions

Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0
Length70 Millimeter
Outer Diameter8 Millimeter
Catheter Gauge8 French
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108809233100455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGECatheter, Biliary, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-08
Device Publish Date2015-09-10

On-Brand Devices [Niti-S Biliary Stent]

08809233102114The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233102091The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233102084The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233102077The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233102060The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233102053The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233102046The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233102039The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233102008The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233101988The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233101971The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233101964The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233101957The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233101940The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233101933The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233101926The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100615The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100592The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100585The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100578The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100561The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100554The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100547The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100530The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100509The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100486The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100479The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100462The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100455The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100448The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100431The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
08809233100424The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.