Duns Number:083171244
Device Description: MINI INTEGRA CSF RES. CONV MODThe silicone elastomer Integra CSF Reservoir, in connection MINI INTEGRA CSF RES. CONV MODThe silicone elastomer Integra CSF Reservoir, in connection with a ventricular catheter, is designed to provide access to the brain and/or cerebrospinal fluid (CSF). Access is obtained by penetrating the reservoir dome with a 25-gauge or smaller needle. In this manner, CSF may be withdrawn or other fluid injected into the reservoir. The mini 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. Since the distal tip of the outlet tube is plugged, conversion to a shunting system requires cutting off the outlet tube proximal to the plugged end for connection to a distal shunt catheter. This model is a flat bottom design. This mini model is not provided with a ventricular catheter and stylet.
Catalog Number
NL83026S03
Brand Name
Integra™ CSF Reservoir
Version/Model Number
NL83026S03
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
0f0916e1-761a-4b05-8c21-d0d8cbb47a8f
Public Version Date
April 07, 2021
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 |