Duns Number:083171244
Device Description: The MoniTorr ICP Pole Mount Assembly with cm H2O and mm Hg Rail provides support and align The MoniTorr ICP Pole Mount Assembly with cm H2O and mm Hg Rail provides support and alignment for External Ventricular Drainage (EVD) Systems. These systems are used for draining cerebrospinal fluid (CSF) from an intraventricular catheter to the external ventricular drainage system.
Catalog Number
INS-305
Brand Name
Integra™
Version/Model Number
INS305
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
b7d110a4-3eba-410d-a4dd-a2cd703ee630
Public Version Date
October 26, 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 |