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
- E1808 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
- E1808 FDA UDI
- Primary DI / UDI-DI
- 08809233103081 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
No
FDA UDI
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
- Catheter Gauge — 16 French FDA UDILength — 8 Centimeter FDA UDIOuter Diameter — 18 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 509fc023-9f6c-4371-bab1-dc14a23cf26d 37 fields · synced May 30, 2026