Duns Number:083171244
Device Description: The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF from the ven The Integra Essential Shunt Kit-Flat Bottom Design is designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. Each kit contains one CSF flushing reservoir with attached 120cm kink-resistant striped peritoneal tubing. The CSF flow control valve is located inside the peritoneal tubing immediately distal to the reservoir. One 18cm ventricular catheter with stylet and one right-angle ventricular catheter guide are also included.
Catalog Number
NL8504120
Brand Name
Integra Essential Shunt Kit Flat Bottom Design
Version/Model Number
NL8504120
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
546dde51-7a5a-4a53-b543-ff42edffe701
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 |