Licox® IT2
GUDID M273IT21
Licox® Complete Brain Tunnelling Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term| Primary Device ID | M273IT21 |
| NIH Device Record Key | 0e39c245-473c-49c0-81b6-9c9219000a1a |
| Commercial Distribution Discontinuation | 2016-08-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Licox® |
| Version Model Number | IT2 |
| Catalog Number | IT2 |
| Company DUNS | 315902197 |
| Company Name | GMS, Gesellschaft für medizinische Sondentechnik mbH |
| 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 | 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
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Handling Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780041207 [Primary] |
| HIBCC | M273IT21 [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 | 4 |
| Public Version Date | 2021-07-22 |
| 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 |
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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