Duns Number:083171244
Device Description: The Allegheny EVD System provides a sterile fluid path for the drainage of CSF from an int The Allegheny EVD System provides a sterile fluid path for the drainage of CSF from an intraventricular catheter to a drainage bag. System components facilitate ventricular drainage, fluid injection, CSF sampling and intracranial pressure monitoring.
Catalog Number
NL8508501
Brand Name
Integra ™ NeuroSciences Allegheny EVD System
Version/Model Number
NL8508501
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
-
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
870b03d4-7a10-4622-9702-e71d3edc7629
Public Version Date
December 15, 2020
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 |