Duns Number:083171244
Device Description: HS ESSENTIAL CSF SHUNT SYSTEMThe Integra Essential Shunt Kit- Burr Hole Design contains on HS ESSENTIAL CSF SHUNT SYSTEMThe Integra Essential Shunt Kit- Burr Hole Design contains one 16mm CSF Flow Control Valve, one 18cm Ventricular Catheter with stylet and one 120cm open-ended peritoneal catheter. The CSF flow control valve, designed for placement in a formal burr hole, is a spherically shaped, silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal low pressure diaphragm for proximal control of CSF flow. The device also provides one-way flow control. The kit is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity.
Catalog Number
NL8504110
Brand Name
Integra Essential Shunt Kit
Version/Model Number
NL8504110
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"
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
K153041,K973525,K153041,K973525
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
97cb97f9-80e8-4152-9627-c39e47ccd6a9
Public Version Date
October 10, 2022
Public Version Number
3
DI Record Publish Date
March 05, 2019
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 |