Duns Number:531408342
Device Description: The Integra NeuroSciences Peritoneal Catheter is a 91 cm silicone elastomer barium sulfate The Integra NeuroSciences Peritoneal Catheter is a 91 cm silicone elastomer barium sulfate striped tubing. Numbered length markers are located 5, 10, 15, 20, 25 and 30 cm from the distal end to assist catheter placement. The distal end of the catheter has four staggered rows of 5.5-mm slits, which are not easily visible. If the distal outlet hole of the catheter becomes obstructed, the slits open for drainage.
Catalog Number
PC1
Brand Name
Peritoneal Catheter
Version/Model Number
PC1
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"
Yes
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
ce5155f7-b5bd-4da3-b6a5-8a20e5f8711d
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
October 01, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |