Licox® IM2

GUDID M273IM21

Licox® Dual Lumen Introducer Kit

GMS, Gesellschaft für medizinische Sondentechnik mbH

Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: M273IM21
• NIH Device Record Key: 68f371d5-c3f9-4897-8b2c-e143f4c58013
• Commercial Distribution Discontinuation: 2023-12-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Licox®
• Version Model Number: IM2
• Catalog Number: IM2
• Company DUNS: 315902197
• Company Name: GMS, Gesellschaft für medizinische Sondentechnik mbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780041108 [Primary]
HIBCC	M273IM21 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002765

FDA Product Code

• GWM: DEVICE, MONITORING, INTRACRANIAL PRESSURE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-03-18
• Device Publish Date: 2015-10-01

On-Brand Devices [Licox®]

• M273PMOBOX1: Licox® PMO Brain Oxygen Monitoring Interface Device
• M273A10US1: Licox® CMP Mains Power Supply
• M273IT21: Licox® Complete Brain Tunnelling Probe Kit
• M273IP2P1: Licox® Complete Brain Probe Kit
• M273IP1P1: Licox® Complete Brain Probe Kit
• M273IM3ST1: Licox® Complete Brain Probe Kit
• M273IM3S1: Licox® Complete Brain Probe Kit
• M273IM2S1: Licox® Complete Brain Probe Kit
• M273IM1S1: Licox® Complete Brain Probe Kit
• M273C8B1: Licox® Temperature Probe
• M273CC1P11: Licox® Combined Oxygen and Temperature Probe
• M273CC1SB1: Licox® Oxygen Probe
• M273VK521: Licox® Parenchymal Probe Guide
• M273IM31: Licox® Triple Lumen Introducer Kit
• M273IM21: Licox® Dual Lumen Introducer Kit