Duns Number:968903703
Device Description: PXB35-09-57-135 STENT VISI PRO 035 V01
Catalog Number
-
Brand Name
Visi-Pro™
Version/Model Number
PXB35-09-57-135
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
P030045
Product Code
FGE
Product Code Name
Stents, drains and dilators for the biliary ducts
Public Device Record Key
4570273a-46a0-470c-8653-c4623de533fb
Public Version Date
April 08, 2022
Public Version Number
3
DI Record Publish Date
September 09, 2018
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |