Licox®

Basic Information

• Brand Name: Licox®
• Primary DI: 10381780041191
• Version / Model: IP2P
• Catalog Number: IP2P
• Company Name: GMS, Gesellschaft für medizinische Sondentechnik mbH
• Labeler DUNS: 315902197
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: e41f1ade-968e-49f4-953a-3b192008391a
• Distribution End Date: 2016-08-04

Device Description

Licox® Complete Brain Probe Kit

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• 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
61398	Intracerebral sensor catheter, short-term	A flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M273IP2P1	HIBCC
Primary	10381780041191	GS1

Premarket Submissions

Submission Number	Supplement Number
K040235	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			130 mm x 35 mm x 313 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away From Sunlight
• Type: Handling Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius