microTargeting™ Array Electrode Carrier and Clamp FC1021

GUDID 10873263000615

Array Electrode Carrier and Clamp for microTargeting(TM) Drive

FHC, INC.

Neurosurgical micro targeting drive
Primary Device ID10873263000615
NIH Device Record Keyac95d685-5818-49eb-b2fe-50f21131c113
Commercial Distribution Discontinuation2025-10-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NamemicroTargeting™ Array Electrode Carrier and Clamp
Version Model NumberFC1021-00061-
Catalog NumberFC1021
Company DUNS108179458
Company NameFHC, INC.
Device Count3
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263006948 [Unit of Use]
GS110873263000615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide


[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide


[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide


[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide


[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide


[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide


[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide


[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-10-02
Device Publish Date2018-07-16

On-Brand Devices [microTargeting™ Array Electrode Carrier and Clamp]

00873263000618Array Electrode Carrier and Clamp for microTargeting(TM) Drive
10873263000615Array Electrode Carrier and Clamp for microTargeting(TM) Drive

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.