Duns Number:083171244
Device Description: MoniTorr ICP Pole Mount Assembly with cm H2O and mm Hg Rail: The Pole Mount Assembly provi MoniTorr ICP Pole Mount Assembly with cm H2O and mm Hg Rail: The Pole Mount Assembly provides support and alignment for the External CSF Drainage and Monitoring Systems (EVD). These systems are used for draining CSF from an intraventricular catheter to the external ventricular drainage system. A Pole Mount Sliding Bracket is supplied with each Pole Mount Assembly. The Pole Mount Sliding Bracket is used to secure the EVD system to the rail on the Pole Mount Assembly.
Catalog Number
INS310
Brand Name
Integra™ MoniTorr ICP™ Pole Mount Assmbly
Version/Model Number
INS310
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
704b6021-d3a4-47a8-b35e-5e2bae7a1218
Public Version Date
December 15, 2020
Public Version Number
5
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 |