Duns Number:690543319
Device Description: MISAGO RX Self-expanding Peripheral Stent
Catalog Number
SX*FMA0680RN
Brand Name
R2P MISAGO
Version/Model Number
SXR06080R
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
ab60b44d-d5d7-4d4a-a32d-73407d43c53e
Public Version Date
April 08, 2022
Public Version Number
3
DI Record Publish Date
August 21, 2019
Package DI Number
54987350727522
Quantity per Package
5
Contains DI Package
04987350727527
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |