Licox ®
GUDID M272IT21
Licox® IT2 Complete Brain Tunneling Probe Kit, consists of CC1P1 Combined Oxygen and Temperature Probe and VK52 Parenchymal Probe Guide
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Intracerebral sensor catheter| Primary Device ID | M272IT21 |
| NIH Device Record Key | f15b27b3-dcf4-491f-b520-c94af26b547b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Licox ® |
| Version Model Number | IT2 |
| Company DUNS | 531408342 |
| Company Name | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged; Keep Away From Sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780041207 [Previous] |
| GS1 | 10381780250340 [Primary] |
| HIBCC | M272IT21 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K053244
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 |
Trademark Results [Licox]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LICOX 78043207 2666518 Live/Registered |
INTEGRA NEUROSCIENCES IMPLANTS (FRANCE)SAS 2001-01-15 |
 LICOX 74527758 1907222 Live/Registered |
INTEGRA NEUROSCIENCES IMPLANTS (FRANCE)SAS 1994-05-23 |
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