Duns Number:989925396
Device Description: The Integra Licox PtO2 Monitor provides functionality for continuously monitoring oxygen p The Integra Licox PtO2 Monitor provides functionality for continuously monitoring oxygen partial pressure (PtO2) in brain tissue. Tissue temperature compensation, which is required for the calculation of PtO2 measurements, mayalso be continuously measured with an accuracy of ± 1°C. To measure PtO2 and temperature tissue compensation continuously, the Integra Licox PtO2 Monitor supports a series of minimally invasive probes that are inserted directly into thepatient.
Catalog Number
LCXO2
Brand Name
LICOX®
Version/Model Number
LCXO2
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
-
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
58a382b3-88d9-434e-ba70-2bcbb21fc932
Public Version Date
October 26, 2022
Public Version Number
9
DI Record Publish Date
December 29, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |
| U | Unclassified | 114 |