Duns Number:083171244
Device Description: Integra™ Ventricular Drainage System provides a sterile path for the drainage of cerebrosp Integra™ Ventricular Drainage System provides a sterile path for the drainage of cerebrospinal fluid (CSF) from an intraventricular catheter to a collection bag. The system can be used for external drainage, and the management of hydrocephalic shunt infections, or treatment of other cerebral conditions such as pre-operative or post-operative pressure monitoring of CSF to control increased intracranial pressure.
Catalog Number
NL850500V
Brand Name
N/A
Version/Model Number
NL850500V
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K932769
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
1a369e21-6544-4ca5-ae99-6ab0c952e701
Public Version Date
October 03, 2022
Public Version Number
5
DI Record Publish Date
February 14, 2017
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 |