Duns Number:083171244
Device Description: CATHETER PUDENZ RT ANG. VENT. STRIPEDThe Integra Pudenz Ventricular Catheter is designed f CATHETER PUDENZ RT ANG. VENT. STRIPEDThe Integra Pudenz Ventricular Catheter is designed for shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The catheter is manufactured from a high durometer silicone elastomer, which helps resist kinking and occlusion caused by the bending or twisting of the catheter. A stripe, made of barium sulfate impregnated silicone elastomer is imbedded in the wall of the catheter. The stripe provides a catheter which is radiopaque throughout its entire length, while keeping barium sulfate away from the surface of the catheter and allowing visual observation of flow through the catheter during implantation. The right-angle model is formed with a right-angle bend .The right-angle bend of this model allows the use of a straight, rather than a right-angle, connector to fasten the catheter to a flat-bottom flushing device. A black, radiopaque marker is located at the right-angle bend to allow the surgeon to easily identify the location of the bend during implantation with a stylet.
Catalog Number
NL8501519
Brand Name
Integra Pudenz Ventricular Catheter
Version/Model Number
NL8501519
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
d0c88165-2bd4-4158-a0c5-4fd6e5163902
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 |