Niti-S Esophageal Stent

Basic Information

Brand Name: Niti-S Esophageal Stent
Primary DI: 08809233103432
Version / Model: ES2006B
Catalog Number: ES2006B
Company Name: TAEWOONGMEDICAL.CO.,LTD
Labeler DUNS: 689484322
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2015-09-10
Public Version: 5
Public Version Date: 2022-11-28
Public Version Status: Update
Public Device Record Key: 3cbaa350-3cc0-44e2-8a05-85e971651b4d

Device 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.

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ESW	Prosthesis, Esophageal	General, Plastic Surgery	878.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61751	Polymer-metal oesophageal stent	A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g., anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809233103432	GS1

Customer Contacts

Phone: +82319960641
Email: [email protected]
Phone: 323-692-0028
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080782	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	20	Millimeter
Length	6	Centimeter
Device Size Text, specify			Catheter Usable Length: 70cm
Catheter Gauge	20	French
Device Size Text, specify			Silicone Cover Length: 3 Centimeter

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius