Esophageal TTS Stent - Fully Covered Esophageal Stent System - TAEWOONGMEDICAL.CO.,LTD

Duns Number:689484322

Device Description: Fully Covered Esophageal Stent System

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More Product Details

Catalog Number

EST2014F

Brand Name

Esophageal TTS Stent

Version/Model Number

EST2014F

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2018

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123205

Product Code Details

Product Code

ESW

Product Code Name

Prosthesis, Esophageal

Device Record Status

Public Device Record Key

33b35e84-e822-4965-a4b0-69e4458a4ac6

Public Version Date

October 26, 2021

Public Version Number

6

DI Record Publish Date

September 10, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TAEWOONGMEDICAL.CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 232