Duns Number:688454359
Device Description: Un-covered self-expanding nitinol biliary stent with Short guidewire system
Catalog Number
-
Brand Name
HANAROSTENT® FAST^TM Biliary (NNN)
Version/Model Number
SHS-10-060-S180
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
K183396
Product Code
FGE
Product Code Name
Catheter, Biliary, Diagnostic
Public Device Record Key
bd5f53a0-7a21-4f36-b13a-c4e3c5a1b73a
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
March 18, 2019
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. | 404 |