Licox®

Basic Information

• Brand Name: Licox®
• Primary DI: 10381780121862
• Version / Model: LCX02
• Catalog Number: LCX02
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-29
• Public Version: 11
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 58a382b3-88d9-434e-ba70-2bcbb21fc932

Device Description

Integra® Licox® PtO2 Monitor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWM	DEVICE, MONITORING, INTRACRANIAL PRESSURE	Neurology	882.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60974	Tissue oxygen monitor	An electrically-powered device intended to be used to continuously measure the partial pressure of oxygen (pO2) in tissues during clinical procedures at high risk for tissue hypoxia (e.g., neurosurgery, skin graft surgery) or during patient critical care (e.g., ICU, PACU); some types may in addition measure tissue temperature. It includes controls, display screen, and cables for connection of dedicated tissue-specific sensors (not included). It may have programmable alarms, internal storage, and ports for peripheral devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M273LCXO21	HIBCC
Primary	10381780121862	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			240mm width x 165mm height x 185mm depth, 3.0kg (6.7lbs) weight

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry