Duns Number:320047483
Device Description: Flexxus® Endoscopic Biliary Stent, 8 mm x 100 mm (190cm deployment system)
Catalog Number
LXB08100
Brand Name
Flexxus® Endoscopic Biliary Stent
Version/Model Number
LXB08100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
6c9b8514-b47e-4e72-a5af-99fae14f9bc5
Public Version Date
April 08, 2022
Public Version Number
3
DI Record Publish Date
October 02, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 174 |