microTargeting™ Platform MP-KIT-P-NB
GUDID 00873263008126
microTargeting™ Ablation Platform, 1x
FHC, INC.
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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