Duns Number:083171244
Device Description: CATH PUD PERIT W/G STRIPEDThe silicone elastomer Pudenz Peritoneal Catheter is designed to CATH PUD PERIT W/G STRIPEDThe silicone elastomer Pudenz Peritoneal Catheter is designed to deliver cerebrospinal fluid (CSF) to the peritoneal cavity through a slit valve near the distal tip. The slit valve consists of four individual slits placed in the catheter wall. The slit valve may be used to control shunt-system closing pressure. It also serves to help resist retrograde flow of fluids into the distal end of the catheter. The closing pressure range is high, which is 95-150 mm of H2O. The graduated model of the Pudenz Peritoneal Catheter is manufactured from a high durometer silicone elastomer, which helps resist kinking and occlusion. The tip of the catheter contains a radiopaque tantalum impregnated, silicone elastomer plug to aid in determining location during and subsequent to implantation. The catheter displays radiopaque markers to allow the surgeon to measure the length of tubing placed within the body during surgery.
Catalog Number
NL8501382
Brand Name
Integra Pudenz Peritoneal Catheter
Version/Model Number
NL8501382
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
e94b3132-a3d9-42e2-9c77-44f3f899c5bd
Public Version Date
February 05, 2021
Public Version Number
4
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 |