Duns Number:988559035
Device Description: Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
Catalog Number
ZIVX5-18-125-8-20
Brand Name
Zilver 518
Version/Model Number
G49319
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 04, 2017
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
NIO
Product Code Name
STENT, ILIAC
Public Device Record Key
ba011055-6365-4524-942b-1bc56382655b
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2014
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. | 888 |
| 3 | A medical device with high risk that requires premarket approval | 165 |