DEVICE: Esophageal TTS Stent (08809744975498)
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If so, send a picture of the label to
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Device Identifier (DI) Information
Esophageal TTS Stent
EST1808F
In Commercial Distribution
EST1808F
TAEWOONGMEDICAL.CO.,LTD
EST1808F
In Commercial Distribution
EST1808F
TAEWOONGMEDICAL.CO.,LTD
Fully Covered Esophageal Stent System
Device Characteristics
| MR Conditional | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| ESW | Prosthesis, Esophageal |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K221482 | 000 |
| K240522 | 000 |
| K243619 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Catheter Usable Length: 180 Centimeter |
| Catheter Gauge: 10.5 French |
| Device Size Text, specify: Silicone Cover Length: 8 Centimeter |
| Length: 8 Centimeter |
| Outer Diameter: 18 Millimeter |
Device Record Status
257fe2bb-a969-401a-8d7c-500caa544477
April 08, 2026
5
June 29, 2022
April 08, 2026
5
June 29, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
323-692-0028
minsoo@taewoongusa.com +82319960641
contact@stent.net
minsoo@taewoongusa.com +82319960641
contact@stent.net