Duns Number:690543319
Device Description: MISAGO RX Self-expanding Peripheral Stent
Catalog Number
SX*FXA06X5LN
Brand Name
Misago®
Version/Model Number
SXR06150L
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
5b3c3460-9317-4874-a696-e2fd21ab7fac
Public Version Date
April 08, 2022
Public Version Number
5
DI Record Publish Date
May 30, 2015
Package DI Number
54987350722145
Quantity per Package
5
Contains DI Package
04987350722140
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 |