Niti-S Esophageal Stent

FDA UDI

Class II (US FDA UDI)

by Taewoong Medical

Identity

Trade Name: Niti-S Esophageal Stent FDA UDI
Generic Name: Bare-metal oesophageal stent FDA UDI
Device Name: The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors. The Niti-S Esophageal Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible, expandable tubular device woven from one or two continuous pieces of Nitinol wire to avoid sharp edges. At each end, the stent has a larger diameter resulting in a “dumbbell” shaped stent when viewed from an axial cross-section. The Niti-S Esophageal Stent is provided in three configurations: the Uncovered type, the Full Covered type and the Both Bare type. The Uncovered-type stent is available in two diameters (6, 8mm), and five lengths (60, 80, 100, 120, and 150mm). The Full Covered-type and the Both Bare-type stents are available in three diameters (6, 8, 10mm), and five lengths (60, 80, 100, 120, and 150mm). It has 10 radiopaque markers. This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency. The introducer system 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 usable lengths of the introducer is 70cm. Other information: The shelf-life of Niti-S Esophageal Stent is 3 years. The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.038 inch (0.97mm). Do not use if package is damaged. Do not reuse or resterilize. FDA UDI
Model / Reference: E1615 FDA UDI
Description: The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors. The Niti-S Esophageal Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible, expandable tubular device woven from one or two continuous pieces of Nitinol wire to avoid sharp edges. At each end, the stent has a larger diameter resulting in a “dumbbell” shaped stent when viewed from an axial cross-section. The Niti-S Esophageal Stent is provided in three configurations: the Uncovered type, the Full Covered type and the Both Bare type. The Uncovered-type stent is available in two diameters (6, 8mm), and five lengths (60, 80, 100, 120, and 150mm). The Full Covered-type and the Both Bare-type stents are available in three diameters (6, 8, 10mm), and five lengths (60, 80, 100, 120, and 150mm). It has 10 radiopaque markers. This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency. The introducer system 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 usable lengths of the introducer is 70cm. Other information: The shelf-life of Niti-S Esophageal Stent is 3 years. The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.038 inch (0.97mm). Do not use if package is damaged. Do not reuse or resterilize. FDA UDI

Identifiers

Catalog Number: E1615 FDA UDI
Primary DI / UDI-DI: 08809233103050 FDA UDI
FDA Product Code: ESW FDA UDI
GMDN Term: Bare-metal oesophageal stent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3610 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

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: Catheter Gauge — 16 French FDA UDI
Length — 15 Centimeter FDA UDI
Outer Diameter — 16 Millimeter FDA UDI

Category: Bare-metal oesophageal stent

Niti-S Esophageal Stent by Taewoong Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal oesophageal stent.

Niti-S Esophageal Stent — Taewoong Medical · Class II
Niti-S Esophageal Stent — Taewoong Medical · Class II
Niti-S Esophageal Stent — Taewoong Medical · Class II
Niti-S Esophageal Stent — Taewoong Medical · Class II
Niti-S Esophageal Stent — Taewoong Medical · Class II
Niti-S Esophageal Stent — Taewoong Medical · Class II
Niti-S Esophageal Stent — Taewoong Medical · Class II
Niti-S Esophageal Stent — Taewoong Medical · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Taewoong Medical

Sources (1)

FDA UDI 8c07a093-0ae4-4989-90fa-308753110c43 37 fields · synced May 30, 2026