Licox®

Basic Information

• Brand Name: Licox®
• Primary DI: 10381780041245
• Version / Model: BC10R
• Catalog Number: BC10R
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 467674f9-d237-4f9c-b305-4e61e1e3430c
• Distribution End Date: 2016-08-02

Device Description

Licox® Test Set

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
36798	Transistor tester	An electronic instrument designed to test the electrical performance of transistors and solid-state diodes to provide verification of their ability to function. It is typically used by biomedical service personnel involved in the repair, servicing, and maintenance of electrical medical devices. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M273BC10R0	HIBCC
Primary	10381780041245	GS1

Premarket Submissions

Submission Number	Supplement Number
K002765	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			250 mm x 180 mm