Duns Number:021717889
Device Description: Closed Cell Self-Expanding Stent
Catalog Number
M001719010
Brand Name
Carotid WALLSTENT®
Version/Model Number
M001719010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P050019,P050019,P050019,P050019,P050019,P050019
Product Code
NIM
Product Code Name
STENT, CAROTID
Public Device Record Key
fa5541f8-5a48-4dac-bf2d-3cb0e2c313e3
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
March 24, 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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |