Picture of 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.

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.

: TAEWOONGMEDICAL.CO.,LTD
: Esophageal TTS Stent
: EST1806F
: EST1806F
: ESW
: Polymer-metal oesophageal stent, sterile
:
: N/A

Source Chain of Custody Credentialed Rating In Stock Price Quantity Exp. Lead times Min. Quantity Quantity Increment
Distributor
N/A
4 pack(s) of 1 1649.20 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:
1
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
Storage handling type:
Storage Environment Temperature
Storage handling high (Unit):
Degrees Celsius
Storage handling high (Value):
40
Storage handling low (Unit):
Degrees Celsius
Storage handling low (Value):
10
IDENTIFIERS
Device Id:
08809293830309
Device type:
Primary

Recall history
Recall Date:
Oct/18/2019
Status:
Ongoing
Recall Number:
Z-1229-2020
View FDA Recall:

Product Documents
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.
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Buy 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. at the best prices. We are a prime supplier of Esophageal TTS Stent Prosthesis, Esophageal medical equipment.
Esophageal TTS Stent
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