Duns Number:806136177
Catalog Number
C06150ML
Brand Name
Cordis S.M.A.R.T. Vascular Stent System
Version/Model Number
C06150ML
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
-
Product Code
NIP
Product Code Name
STENT, SUPERFICIAL FEMORAL ARTERY
Public Device Record Key
f27562d5-9825-4ce1-a40a-9c93475d7ebf
Public Version Date
August 05, 2022
Public Version Number
8
DI Record Publish Date
September 19, 2014
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. | 2567 |
3 | A medical device with high risk that requires premarket approval | 204 |