Duns Number:480186617
Device Description: Licox® IP2P Complete Brain Probe Kit, Dual lumen, consists of Licox® I2P Dual Lumen Introd Licox® IP2P Complete Brain Probe Kit, Dual lumen, consists of Licox® I2P Dual Lumen Introducer Kit and CC1P1 Combined Oxygen and Temperature Probe
Catalog Number
IP2P
Brand Name
Licox ®
Version/Model Number
IP2P
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
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
K040235,K040235
Product Code
GWM
Product Code Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Public Device Record Key
cae59b2e-570e-4571-a7d0-81106b610ee5
Public Version Date
October 25, 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 |