Duns Number:945543689
Device Description: The Prestige Coil System is indicated for arterial and venous embolizations in the periphe The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature. It is designed for use with the Ultra Detachment Controller.
Catalog Number
-
Brand Name
Prestige Coil System
Version/Model Number
PRES0153CXPPL
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
K200030
Product Code
KRD
Product Code Name
Device, Vascular, For Promoting Embolization
Public Device Record Key
5d80203a-7eea-46c6-845a-c84e5d41c638
Public Version Date
October 13, 2021
Public Version Number
1
DI Record Publish Date
October 05, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 757 |