Duns Number:168593429
Device Description: NanoCoated Coronary Stent System
Catalog Number
170-03-30018
Brand Name
Cobra PzF
Version/Model Number
170-03-30018
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"
Yes
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
P160014
Product Code
MAF
Product Code Name
Stent, Coronary
Public Device Record Key
cb560cd6-b860-4d4d-9943-d1f35a7c0fb7
Public Version Date
October 07, 2019
Public Version Number
4
DI Record Publish Date
October 20, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 46 |
3 | A medical device with high risk that requires premarket approval | 30 |