microTargeting™Array Electrode Insertion Tube Set FC1012

GUDID 00873263001530

microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6 of IT(AR1), 6 of IT(AR2), and 1 of IT(AR3). Individual Specifications: IT(AR1): Electrode Insertion Tube - 239.9mm, OD=0.88mm, ID=0.58mm. IT(AR2): Lower Guide Spacer - OD=1.83mm, ID=0.97mm (does not enter brain). IT(AR3): Lead Insertion Tube - 239.9mm, OD=1.83mm, ID=1.60mm. Also contains one 66-AC-AR Array Electrode Carrier and one 66-CN-ET Electrode Extraction Tool.

FHC, INC.

Intracerebral cannula, implantable
Primary Device ID00873263001530
NIH Device Record Keyc7dd5cd3-cd7c-4d5e-8c9a-83f6620b03d8
Commercial Distribution Discontinuation2023-01-10
Commercial Distribution StatusIn Commercial Distribution
Brand NamemicroTargeting™Array Electrode Insertion Tube Set
Version Model NumberFC1012-00153
Catalog NumberFC1012
Company DUNS108179458
Company NameFHC, INC.
Device Count1
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 Datetrue
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

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263001530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00873263001530]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-20
Device Publish Date2017-09-09

On-Brand Devices [microTargeting™Array Electrode Insertion Tube Set]

00873263001530microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains
00873263007600microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains

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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