Auragen™
GUDID M272AU8X8P4V1
The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode| Primary Device ID | M272AU8X8P4V1 |
| NIH Device Record Key | 0aae7dea-2e10-4014-94ae-4417cec543b0 |
| Commercial Distribution Discontinuation | 2023-12-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Auragen™ |
| Version Model Number | AU8X8P4V |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| 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 |
| 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 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780036678 [Primary] |
| HIBCC | M272AU8X8P4V1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082250
FDA Product Code
| GYC | ELECTRODE, CORTICAL |
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 | 2024-03-18 |
| Device Publish Date | 2016-08-08 |
On-Brand Devices [Auragen™]
| M272AU8D5L251 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU8D10L51 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU8D10L251 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU6D5L251 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU6D10L51 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU6D10L251 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU4D5L251 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU4D10L51 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU4D10L251 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU12D5L251 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU10D5L251 | The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrica |
| M272AU8X8P81 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X8P4V1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X8P4S1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X8P4M751 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X8P4M41 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X8P41 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X8P14SV1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X8P14S1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X8P14M751 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X8P14M41 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X4P141 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X2P4CD1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X2P2CDL1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X2P2C1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU8X1P1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU6X8P61 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU6X8P31 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU6X6P3S1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU6X2P2CD1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU6X2P1C1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU5X8P151 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU4X8P41 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU4X8P21 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU4X8P121 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU4X6P21 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU4X5P21 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU4X5P121 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU4X4P11 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU4X2P2CD1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU4X2P1C1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU2X8P21 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU2X8P11 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU2X6P11 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU2X4P11 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU1X8PN1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU1X8PD21 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU1X8P1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU1X6PN1 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
| M272AU1X6PM751 | The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortica |
Trademark Results [Auragen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AURAGEN 90455714 not registered Live/Pending |
Phyto Tech Corp. 2021-01-08 |
 AURAGEN 88930864 not registered Live/Pending |
Reversal Solutions, Inc. 2020-05-23 |
 AURAGEN 75977693 2202313 Live/Registered |
AURA SYSTEMS, INC. 1996-07-29 |
 AURAGEN 75397439 2231898 Dead/Cancelled |
CATALYST DIRECT, INC. 1997-11-28 |
 AURAGEN 75345482 2195671 Dead/Cancelled |
Cote, Kiya 1997-08-22 |
 AURAGEN 75141345 not registered Dead/Abandoned |
AURA SYSTEMS, INC. 1996-07-29 |
 AURAGEN 73432251 1330616 Dead/Cancelled |
Auragen Systems Corp. 1983-06-27 |
 AURAGEN 73432250 1330615 Dead/Cancelled |
Auragen Systems Corp. 1983-06-27 |
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