Duns Number:079720472
Device Description: Z-Stent Esophageal with Dua Anti-Reflux Valve
Catalog Number
EZS-25-14-70-AR
Brand Name
Z-Stent
Version/Model Number
G24872
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 05, 2016
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ESW
Product Code Name
PROSTHESIS, ESOPHAGEAL
Public Device Record Key
c68c92fb-571d-4733-be43-42c8605105c5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 03, 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 | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |