Duns Number:083171244
Device Description: The Evolution Pole Mount Assembly provides support and alignment for the External CSF Drai The Evolution Pole Mount Assembly provides support and alignment for the External CSF Drainage and Monitoring Systems. These systems are used for draining CSF from an intraventricular or lumbar catheter to an external CSF drainage system. This Integra Pole Mount is provided with a laser leveling device and an optional line level. The laser level is attached via a bracket.
Catalog Number
INS410
Brand Name
LimiTorr™
Version/Model Number
INS410
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
-
For Single-Use
-
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
K062599
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
55fc0daf-3d89-462d-a27f-6b13d9867904
Public Version Date
October 03, 2022
Public Version Number
6
DI Record Publish Date
September 22, 2015
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 |