Licox® IT2
GUDID M273IT21
Licox® Complete Brain Tunnelling Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
Intracerebral sensor catheter| 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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