DEVICE: Esophageal TTS Stent (08809744973449)
Device Identifier (DI) Information
Esophageal TTS Stent
EST2015B-22
In Commercial Distribution
TAEWOONGMEDICAL.CO.,LTD
EST2015B-22
In Commercial Distribution
TAEWOONGMEDICAL.CO.,LTD
Partially 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 [?] |
|---|---|
| K211706 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Stent Diameter: 20 Millimeter |
| Stent Length: 15 Centimeter |
| Catheter Working Length: 220 Centimeter |
| Device Size Text, specify: 15 mm bare at both ends of the Stent |
Device Record Status
1a6deed5-7481-424d-bf34-99c9656b5c03
November 28, 2022
2
October 15, 2021
November 28, 2022
2
October 15, 2021
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