Duns Number:083171244
Device Description: The Pudenz Ventricular Catheter is designed for shunting CSF from the ventricles of the br The Pudenz Ventricular Catheter is designed for shunting CSF from the ventricles of the brain. The Graduated Small Model has a slightly smaller outside diameter, and is made of a lower durometer (softer) silicone elastomer.
Catalog Number
NL8501504
Brand Name
Integra Pudenz Ventricular Catheter
Version/Model Number
NL8501504
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
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
4de3cfe8-4858-42cb-97e2-b787677e2e61
Public Version Date
September 22, 2020
Public Version Number
3
DI Record Publish Date
December 15, 2016
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |