Duns Number:083171244
Device Description: MINI INTEGRA FLAT BOTTOMThe silicone elastomer Integra CSF Reservoir, in connection with a MINI INTEGRA FLAT BOTTOMThe 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 In this manner, CSF may be withdrawn or other fluid injected into the reservoir.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, dual side inlet reservoir’s inlet tubing enters from the sides of the reservoir rather than from the base. This flat bottom dual side inlet design eliminates the need for a formal burr hole, provides greater latitude in positioning and allows the ventricular catheter to be revised without disturbing the reservoir.
Catalog Number
NL83026S04
Brand Name
Integra™ CSF Reservoir
Version/Model Number
NL83026S04
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
2cee693e-a5bc-40d9-abe4-94d61b7b08b8
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 |