Duns Number:480186617
Device Description: Licox® IT2 Complete Brain Tunneling Probe Kit, consists of CC1P1 Combined Oxygen and Temp Licox® IT2 Complete Brain Tunneling Probe Kit, consists of CC1P1 Combined Oxygen and Temperature Probe and VK52 Parenchymal Probe Guide
Catalog Number
IT2
Brand Name
Licox ®
Version/Model Number
IT2
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"
-
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
K053244,K053244
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
f15b27b3-dcf4-491f-b520-c94af26b547b
Public Version Date
October 26, 2022
Public Version Number
8
DI Record Publish Date
August 04, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 69 |