Duns Number:480186617
Device Description: The Integra OSV II Lumbar hydrocephalus Valve System is an implantable device for controll The Integra OSV II Lumbar hydrocephalus Valve System is an implantable device for controlled cerebrospinal fluid (CSF) drainage from the lumbar subarachnoid region to the peritoneal cavity. Unlike conventional valves, the OSV II Lumbar Valve System is a variable resistance valve which maintains drainage rate close to the CSF secretion rate (20 ml/hr) within the physiological range of intracranial pressure (ICP). The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension.
Catalog Number
909711
Brand Name
OSV II Lumbar Valve System
Version/Model Number
909711
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
K092395,K140722
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
68511181-6f71-476f-9a4d-2f74b10ef191
Public Version Date
October 26, 2022
Public Version Number
6
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 69 |