The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors. The device consists of an implantable stent and an introducer for delivering 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 esophagus. The stents are available in two configurations (Full Covered and Both Bare) with two body diameters (18 and 20mm) and six lengths (6, 8, 10, 12, 14, and 15cm). The stents with both 18mm and 20mm diameter of body have the same diameter (26mm) for their both dumbbell shaped heads. It has 10 radiopaque markers.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 esophagus to establish patency. The introducer of Esophageal TTS Stent is Through The Scope introducer which is intended to be inserted through an endoscope channel. All of the components of the introducers are supplied sterile in a disposable package. The usable lengths of the introducer is 180cm. Other information: The shelf-life of Esophageal TTS Stent is 3 years.The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.035 inch.Do not use if package is damaged. Do not reuse or resterilize.

Manufacturer : TAEWOONGMEDICAL.CO.,LTD

Brand : Esophageal TTS Stent

MFG item # : EST2010F

Catalog # : EST2010F

FDA Product Code Name : ESW

GMDN Term Name : Polymer-metal oesophageal stent, sterile

FDA Recall Link :

Package quantity : N/A

Source	Chain of Custody	Credentialed	Rating	In Stock	Price	Quantity	Exp.	Lead times	Min. Quantity	Quantity Increment
Distributor			N/A	2 pack(s) of 1	1804.60			1-2 days	1	1

Product classification

Product classification:

Prosthesis, Esophageal

Product code:

ESW

GTIN:

true

GMDN

Code:

Polymer-metal oesophageal stent, sterile

Description:

A sterile, 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.

DEVICE

Single Use:

Otc:

Rx:

Device distribution status:

In Commercial Distribution

Device count:

Device kit:

Lot batch:

Serial number:

true

Manufacturing date:

true

Expiration date:

STERILIZATION METHOD TYPES

Additional information

DEVICE SIZES

Device sizes type:

Device Size Text, specify

Device size text:

Catheter Usable Length: 180 Centimeter

ENVIRONMENTAL CONDITIONS

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Storage Environment Temperature

Storage handling high (Unit):

Degrees Celsius

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Storage handling low (Unit):

Degrees Celsius

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IDENTIFIERS

Device Id:

08809293832389

Device type:

Primary

Recall history

Recall Date:

Oct/18/2019

Status:

Ongoing

Recall Number:

Z-1229-2020

View FDA Recall:

Click here

Product Documents