Duns Number:083171244
Device Description: The silicone elastomer Integra CSF Reservoir, in connection with a ventricular catheter, i The silicone elastomer Integra CSF Reservoir, in connection with a ventricular catheter, is designed to provide access to the brain and/or CSF. The Convertible model incorporates an outlet tube in addition to an inlet tube. The outlet tube may be connected to a distal catheter, allowing the reservoir to be used in a shunting system, if later indicated. The 2.5cm base diameter reservoir is a flat bottom design; the 1.5cm base diameter reservoir is a burr-hole model.
Catalog Number
NL79034S02
Brand Name
Dual Outlet Convertible Integra™ Reservoir
Version/Model Number
NL79034S02
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
-
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
e744a3cf-4e1e-48da-8e5c-48d9591fc683
Public Version Date
September 22, 2020
Public Version Number
3
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 |