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Niti-S Biliary Stent

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref BD1012

by Taewoong Medical

Identity

Trade Name
Niti-S Biliary Uncovered Stent [D-Type] EUDAMED
Niti-S Biliary Stent FDA UDI
Generic Name
Bare-metal biliary stent FDA UDI
Device Name
Niti-S Biliary Uncovered Stent [D-Type] EUDAMED
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. FDA UDI
Model / Reference
BD1012 EUDAMEDFDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
BD1012 FDA UDI
Primary DI / UDI-DI
08809233102114 EUDAMEDFDA UDI
Basic UDI-DI
B-08809233102114 EUDAMED
510(k) Number
K073667 FDA UDI
FDA Product Code
FGE FDA UDI
EMDN Code
P0502 BILIARY AND PANCREATIC PROSTHESES EUDAMED
GMDN Term
Bare-metal biliary stent FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 120 Millimeter FDA UDI
Outer Diameter — 10 Millimeter FDA UDI
Catheter Gauge — 8 French FDA UDI

Category: Bare-metal biliary stent

Niti-S Biliary Stent by Taewoong Medical — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal biliary stent.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Taewoong Medical

Sources (2)

  • FDA UDI 9e2ad569-b4d4-4a27-b316-063fd3a78c3c 38 fields · synced Jun 19, 2026
  • EUDAMED a49f6531-31c4-4bf1-9f36-8babff62b47e 61 fields · synced Jun 19, 2026