Licox® BC10TV
GUDID 10381780250104
The Integra Licox probe cables and probe extension cables are the interface between the Integra Licox monitor ans the probes that are used to measure intracranial pressire and temperature. The probe cables and extensions connect the Licox monitor to the Licox probes. The Licox probe cables and probe extension cables are reusable products.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Electrical-only medical device connection cable, reusable| Primary Device ID | 10381780250104 |
| NIH Device Record Key | 8d6018c0-169b-412c-bbdb-2b92a800840f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Licox® |
| Version Model Number | BC10TV |
| Catalog Number | BC10TV |
| Company DUNS | 989925396 |
| Company Name | INTEGRA LIFESCIENCES (IRELAND) LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Temperature -20°C to 50°C (-4°F to 122°F); Relative Humidity non-condensing 25% to 80%; Avoid excess heat and humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780041276 [Previous] |
| GS1 | 10381780250104 [Primary] |
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 | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-05-20 |
| Device Publish Date | 2016-08-02 |
On-Brand Devices [Licox®]
| 10381780250104 | The Integra Licox probe cables and probe extension cables are the interface between the Integra |
| 10381780250081 | The Integra Licox probe cables and probe extension cables are the interface between the Integra |
| 10381780250067 | The Integra Licox probe cables and probe extension cables are the interface between the Integra |
| 10381780250050 | The Integra Licox probe cables and probe extension cables are the interface between the Integra |
| 10381780250043 | The Integra Licox probe cables and probe extension cables are the interface between the Integra |
| M273LCXO21 | The Integra Licox PtO2 Monitor provides functionality for continuously monitoring oxygen partial |
| 10381780250128 | The Integra Licox probe cables and probe extension cables are the interface between the Integra |
| 10381780250111 | The Integra Test Set is used to test Licox monitor calibration accuracy of the PtO2 measurments |
| 10381780250074 | The Integra Licox probe cables and probe extension cables are the interface between the Integra |
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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