Niti-S Biliary Uncovered Stent [D-Type]

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref TD1008

by Taewoong Medical Co., Ltd.

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: TD1008 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: TD1008 FDA UDI
Primary DI / UDI-DI: 08809233100578 EUDAMEDFDA UDI
Basic UDI-DI: B-08809233100578 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: Northern Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 80 Millimeter FDA UDI
Outer Diameter — 10 Millimeter FDA UDI
Catheter Gauge — 8 French FDA UDI

Niti-S Biliary Uncovered Stent [D-Type] by Taewoong Medical Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-08809233100578	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Taewoong Medical Co., Ltd.
EUDAMED SRN: KR-MF-000007515
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (2)

EUDAMED 0c107738-689c-4d14-8432-2da2f3311c2c 61 fields · synced Jun 18, 2026
FDA UDI 639b8955-6eb1-464a-81f9-b35bc37a6f7c 38 fields · synced May 30, 2026