Duns Number:531408342
Device Description: The Integra NeuroSciences Ventricular Catheter is a 25 cm silicone elastomer tubing with f The Integra NeuroSciences Ventricular Catheter is a 25 cm silicone elastomer tubing with full barium impregnation. Numbered length markers are located 5 and 10 cm from the proximal end. Length marker dots are located at 1 cm increments 3 to 14 cm from the proximal end. The proximal end presents fourty (40) flow holes. The proximal tip is constructed of molded, barium sulfate impregnated silicone to provide smooth, consistent end, which aid catheter placement. A stainless steel stylet and a right angle guide are provided.
Catalog Number
VC1
Brand Name
Straight Ventricular Catheter
Version/Model Number
VC1
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
e27447aa-7142-4b00-b6dd-bf81a250fcb2
Public Version Date
March 29, 2018
Public Version Number
2
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 |