Licox ®

GUDID M272C8B1

Licox® C8B Temperature Probe is intended for use with Licox® Monitor Systems for short-term monitoring (5 days maximum use) of temperature in cerebral tissue. Contains: Probe, Protection Tube, Plausibility Check Test tube

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

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• Primary Device ID: M272C8B1
• NIH Device Record Key: 2f332cf0-d32d-479b-9e9f-c22a52aa80d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Licox ®
• Version Model Number: C8B
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• 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: true
• Manufacturing Date: true
• 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

Customer Support Contacts

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• Email: custsvcnj@integralife.com
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780041085 [Previous]
GS1	10381780250159 [Primary]
HIBCC	M272C8B1 [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: 5
• Public Version Date: 2021-07-22
• Device Publish Date: 2016-08-04

On-Brand Devices [Licox ®]

• M272IT21: Licox® IT2 Complete Brain Tunneling Probe Kit, consists of CC1P1 Combined Oxygen and Temperatu
• M272IP2P1: Licox® IP2P Complete Brain Probe Kit, Dual lumen, consists of Licox® I2P Dual Lumen Introducer
• M272IP1P1: Licox® IP1P Complete Brain Probe Kit, Single lumen, consists of Licox® IP1 Single Lumen Introd
• M272IM3ST1: Licox® IM3ST Complete Brain Probe Kit, Triple lumen, consists of Licox® IM3 Triple Lumen Intro
• M272IM1S1: Licox® IM1S Complete Brain Probe Kit, Single lumen, consists of Licox® IM1 Single Lumen Introd
• M272CC1SB1: Licox® CC1SB Oxygen Probe is intended for use with Licox® Monitor Systems for short-term moni
• M272CC1P11: Licox® CC1P1 Combined Oxygen and Temperature Probe is intended for use with Licox® Monitor S
• M272C8B1: Licox® C8B Temperature Probe is intended for use with Licox® Monitor Systems for short-term m
• M272VK521: Licox® VK52 Parenchymal Probe Guide is used for tunneling Licox CC1P1 subcutaneously under the