microTargeting™ Electrode and Insertion Tube Kit FC4001

GUDID 10873263001162

microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive. Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode. 1x IT(DB3) Insertion tube with Stylet. 1x PT(DB5) Protective Tube. Individual Specifications: MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L) IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id

FHC, INC.

Depth electrode
Primary Device ID10873263001162
NIH Device Record Key716a4278-92c6-4228-a539-f55da62308a6
Commercial Distribution Discontinuation2023-01-10
Commercial Distribution StatusIn Commercial Distribution
Brand NamemicroTargeting™ Electrode and Insertion Tube Kit
Version Model NumberFC4001-00116
Catalog NumberFC4001
Company DUNS108179458
Company NameFHC, INC.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100873263001165 [Unit of Use]
GS110873263001162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10873263001162]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-20
Device Publish Date2016-08-22

On-Brand Devices [microTargeting™ Electrode and Insertion Tube Kit]

00873263005088microTargeting Frame Kit D.ZAP/Lead Insertion, 1x, Sterile, for use with mT Drive or STar Drive.
10873263001346microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame
10873263001322Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTarg
10873263001162microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDri
10873263007584microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame
10873263007560Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTarg
10873263007546microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDri

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.