Duns Number:687784405
Catalog Number
-
Brand Name
BONASTENT® Biliary
Version/Model Number
BB-101018
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
K140760
Product Code
FGE
Product Code Name
Catheter, Biliary, Diagnostic
Public Device Record Key
2340a4f0-7db6-49db-b3a3-3b05ccc429f5
Public Version Date
April 08, 2022
Public Version Number
5
DI Record Publish Date
March 03, 2017
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. | 107 |