microTargeting™ Platform Accessory MP-KIT-A-LG

GUDID 00873263006009

microTargeting Epilepsy Grid, Large. For use with Epilepsy Orthogonal - Oblique Platform

FHC, INC.

Neurological stereotactic surgery system
Primary Device ID00873263006009
NIH Device Record Key73021d0f-759f-4e8d-a76c-1ce4bed4ccd8
Commercial Distribution StatusIn Commercial Distribution
Brand NamemicroTargeting™ Platform Accessory
Version Model NumberMP-KIT-A-LG-00600
Catalog NumberMP-KIT-A-LG
Company DUNS108179458
Company NameFHC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
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 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263006009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00873263006009]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-01
Device Publish Date2019-06-21

On-Brand Devices [microTargeting™ Platform Accessory]

00873263005392microTargeting Epilepsy Grid, Small. For use with Epilepsy Orthogonal - Oblique Platform.
00873263005378microTargeting Epilepsy Grid, Large. For use with Epilepsy Orthogonal - Oblique Platform
00873263004159Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
00873263004142Peek Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform
00873263004135Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
00873263004081Stainless Steel Mounting Thumbknobs, nonsterile. For use with microTargeting Platform
00873263003794Customized Phantom, for use with microTargeting Platform
00873263003671Peek Thumb-Knobs, nonsterile, for use with microTargeting Platform
00873263006009microTargeting Epilepsy Grid, Large. For use with Epilepsy Orthogonal - Oblique Platform
00873263005996microTargeting Epilepsy Grid, Small. For use with Epilepsy Orthogonal - Oblique Platform.
00873263005958Patient specific Phantom, for use with microTargeting Platform
10873263006259Stainless Steel Mounting Thumbknobs, Nonsterile, 50X. For use with microTargeting Platform
00873263008447Six-Trajectory Bilateral Platform Phantom
10873263006266Stainless Steel Thumbknobs, nonsterile, 50X. For use with microTargeting Platform.

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.