microTargeting™ Platform MP-KIT-P-NB

GUDID 00873263008126

microTargeting™ Ablation Platform, 1x

FHC, INC.

Neurological stereotactic surgery system
Primary Device ID00873263008126
NIH Device Record Keycd968d47-046b-428c-b04e-f333d21c9be3
Commercial Distribution StatusIn Commercial Distribution
Brand NamemicroTargeting™ Platform
Version Model NumberMP-KIT-P-NB-00812
Catalog NumberMP-KIT-P-NB
Company DUNS108179458
Company NameFHC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com
Phone+1(800)326-2905
Emailfhcinc@fh-co.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263008126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-31

On-Brand Devices [microTargeting™ Platform]

00873263004258microTargeting Four Legged Unilateral Platform, 1x, nonsterile. Patient customized.
00873263004241microTargeting Three Legged Unilateral Platform, 1x, nonsterile. Patient customized.
00873263004180microTargeting Epilepsy Platform, Multi-Oblique, 1x, nonsterile
00873263004173microTargeting Epilepsy Platform, orthogonal - oblique, 1x, nonsterile
00873263004166Bilateral Platform, patient customized
00873263001813microTargeting, Multi-Oblique, Single Trajectory Platform, 1x, nonsterile
00873263001806microTargeting Multi-Oblique Dual Trajectory Platform, 1x, nonsterile
10873263004231microTargeting Staged Bilateral Platforms, nonsterile, patient customized
10873263005924microTargeting Staged Bilateral Platforms, nonsterile, patient specific
00873263005989microTargeting Multi-Oblique Dual Trajectory Platform, 1x, nonsterile
00873263005972microTargeting, Multi-Oblique, Single Trajectory Platform, 1x, nonsterile
00873263005965microTargeting Epilepsy Platform, Multi-Oblique, 1x, nonsterile
00873263005941microTargeting Four Legged Unilateral Platform, 1x, nonsterile. Patient specific.
00873263005934microTargeting Three Legged Unilateral Platform, 1x, nonsterile. Patient specific.
00873263005910microTargeting Epilepsy Platform, orthogonal - oblique, 1x, nonsterile
00873263005903Bilateral Platform, patient specific
00873263008126microTargeting™ Ablation Platform, 1x
00873263008478Entry Offset Positioner (2mm I.D.)
00873263008461Center Positioner (2mm I.D.)
00873263008430Six-Trajectory Bilateral Platform
00873263008522microTargeting™ Platform Shaving Template

Trademark Results [microTargeting]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MICROTARGETING
MICROTARGETING
78392262 not registered Dead/Abandoned
TargetPoint Consulting, Inc
2004-03-29
MICROTARGETING
MICROTARGETING
76709829 4259360 Dead/Cancelled
Siren Interactive Corp.
2011-11-23
MICROTARGETING
MICROTARGETING
74600530 1921303 Dead/Cancelled
MBV, INC.
1994-11-18

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