Duns Number:988559035
Device Description: Zilver 635 Biliary Stent, Expandable Metal Biliary Stent System
Catalog Number
ZILBS-635-8-8
Brand Name
Zilver 635
Version/Model Number
G50623
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
FGE
Product Code Name
CATHETER, BILIARY, DIAGNOSTIC
Public Device Record Key
c161e231-9b0f-472b-a560-d1fe39fd4448
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
October 24, 2015
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 |