Duns Number:690543319
Device Description: MISAGO RX Self-expanding Peripheral Stent
Catalog Number
SX*FXA0680LN
Brand Name
Misago®
Version/Model Number
SXR06080L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
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
bca4bc31-2f14-495a-9e76-037143ec87d5
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
May 30, 2015
Package DI Number
54987350722107
Quantity per Package
5
Contains DI Package
04987350722102
Package Discontinue Date
December 31, 9999
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 |