microTargeting™ Platform MP-KIT-P-NB
GUDID 00873263008126
microTargeting™ Ablation Platform, 1x
FHC, INC.
Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system| Primary Device ID | 00873263008126 |
| NIH Device Record Key | cd968d47-046b-428c-b04e-f333d21c9be3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | microTargeting™ Platform |
| Version Model Number | MP-KIT-P-NB-00812 |
| Catalog Number | MP-KIT-P-NB |
| Company DUNS | 108179458 |
| Company Name | FHC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00873263008126 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092192
FDA Product Code
| HAW | Neurological stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[00873263008126]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-08 |
| Device Publish Date | 2020-05-31 |
On-Brand Devices [microTargeting™ Platform]
| 00873263004258 | microTargeting Four Legged Unilateral Platform, 1x, nonsterile. Patient customized. |
| 00873263004241 | microTargeting Three Legged Unilateral Platform, 1x, nonsterile. Patient customized. |
| 00873263004180 | microTargeting Epilepsy Platform, Multi-Oblique, 1x, nonsterile |
| 00873263004173 | microTargeting Epilepsy Platform, orthogonal - oblique, 1x, nonsterile |
| 00873263004166 | Bilateral Platform, patient customized |
| 00873263001813 | microTargeting, Multi-Oblique, Single Trajectory Platform, 1x, nonsterile |
| 00873263001806 | microTargeting Multi-Oblique Dual Trajectory Platform, 1x, nonsterile |
| 10873263004231 | microTargeting Staged Bilateral Platforms, nonsterile, patient customized |
| 10873263005924 | microTargeting Staged Bilateral Platforms, nonsterile, patient specific |
| 00873263005989 | microTargeting Multi-Oblique Dual Trajectory Platform, 1x, nonsterile |
| 00873263005972 | microTargeting, Multi-Oblique, Single Trajectory Platform, 1x, nonsterile |
| 00873263005965 | microTargeting Epilepsy Platform, Multi-Oblique, 1x, nonsterile |
| 00873263005941 | microTargeting Four Legged Unilateral Platform, 1x, nonsterile. Patient specific. |
| 00873263005934 | microTargeting Three Legged Unilateral Platform, 1x, nonsterile. Patient specific. |
| 00873263005910 | microTargeting Epilepsy Platform, orthogonal - oblique, 1x, nonsterile |
| 00873263005903 | Bilateral Platform, patient specific |
| 00873263008126 | microTargeting™ Ablation Platform, 1x |
| 00873263008478 | Entry Offset Positioner (2mm I.D.) |
| 00873263008461 | Center Positioner (2mm I.D.) |
| 00873263008430 | Six-Trajectory Bilateral Platform |
| 00873263008522 | microTargeting™ Platform Shaving Template |
Trademark Results [microTargeting]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICROTARGETING 78392262 not registered Dead/Abandoned |
TargetPoint Consulting, Inc 2004-03-29 |
 MICROTARGETING 76709829 4259360 Dead/Cancelled |
Siren Interactive Corp. 2011-11-23 |
 MICROTARGETING 74600530 1921303 Dead/Cancelled |
MBV, INC. 1994-11-18 |
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