Duns Number:689484322
Device Description: Fully Covered Esophageal Stent System
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
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
ESW
Product Code Name
Prosthesis, Esophageal
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |