Duns Number:480186617
Device Description: Licox® IP2 Dual Lumen Introducer Kit contains is used to insert the combined oxygen/temper Licox® IP2 Dual Lumen Introducer Kit contains is used to insert the combined oxygen/temperature probe and the ICP Catheter. It contains: Dual lumen Introducer, Guidewire, Compression Cap, Bolt, Drill Bit, Drill stop with set screw, Hex wrench, Stylet, Compression cap fitting, ICP obturator.
Catalog Number
IP2
Brand Name
Licox ®
Version/Model Number
IP2
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
29d9bbb2-686b-4cbb-8626-13073d7fca48
Public Version Date
October 25, 2022
Public Version Number
6
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 |