Duns Number:964569052
Device Description: Supera Peripheral Stent System 5.5 mm x 120 mm x 120 cm 6 F
Catalog Number
S-55-120-120-P6
Brand Name
SUPERA
Version/Model Number
S-55-120-120-P6
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
2247803a-fa60-497f-9281-2fb0e7e54afa
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
April 13, 2018
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 |