Duns Number:964569052
Device Description: Supera Peripheral Stent System 6.5 mm x 150 mm x 120 cm 6 F
Catalog Number
S-65-150-120-P6
Brand Name
SUPERA
Version/Model Number
S-65-150-120-P6
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2020
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
9d4e5b2d-602a-472e-9c83-464bf23a9365
Public Version Date
April 08, 2022
Public Version Number
5
DI Record Publish Date
January 22, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 964 |
| 3 | A medical device with high risk that requires premarket approval | 775 |