Duns Number:964569052
Device Description: XIENCE Skypoint Everolimus Eluting Coronary Stent System 4.00 mm x 12 mm / Rapid-Exchange
Catalog Number
1804400-12
Brand Name
XIENCE SKYPOINT
Version/Model Number
1804400-12
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NIQ
Product Code Name
Coronary drug-eluting stent
Public Device Record Key
60e79654-7a67-44e0-aa7f-dd02ac14d161
Public Version Date
February 21, 2022
Public Version Number
3
DI Record Publish Date
May 27, 2021
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 |