FHC, INC.

Address:1201 MAIN ST,Bowdoin,ME,04287,US

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- Catalog Number : FC1020

Device Description : microTargeting Electrode Cable

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

- Catalog Number : FC1011

Device Description : microTargeting Single Electrode Insertion Tube SetContains: 66-IT-01 (One IT(BP microTargeting Single Electrode Insertion Tube SetContains: 66-IT-01 (One IT(BP2), One PT(BP2), One Spacer Cleaning Tool, One Electrode Carrier, One Shielded Electrode Carrier) depth when used with frame and Star or mT Drive is 40mm above target Individual Specifications: IT(BP2): Length=183mm, OD=1.83mm, ID=1.60mmPT(BP2): Length=181mm, OD=1.47mm, ID=0.99mm

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : FC1012

Device Description : microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT D 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.

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 66-EL-EC

Device Description : microTargeting Electrode Cable, Sterile, for use with microTargeting Electrodes

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

- Catalog Number : MP-KIT-P-ED

Device Description : microTargeting Multi-Oblique Dual Trajectory Platform, 1x, nonsterile

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : MP-KIT-P-ES

Device Description : microTargeting, Multi-Oblique, Single Trajectory Platform, 1x, nonsterile

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 66-IT(DB14)

Device Description : microTargeting Insertion Tube with Stylet, nonsterile

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 70-ZD-ME

Device Description : STar(TM) Drive ME, Motor/Encoder Version

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 70-ZD-MA

Device Description : STar(TM) Drive MA, Manual Operation Only

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

- Catalog Number : 70-IT-AR

Device Description : STar(TM) Drive Array Electrode Insertion Tube Set for use with stereotactic fram STar(TM) Drive Array Electrode Insertion Tube Set for use with stereotactic frames, non-sterileContains:6 - IT(AR16) Guide Tube (does not enter brain)6 - IT(AR17) Insertion Tube with Stylet - 241.5mm length, 0.90mm od, 0.60mm id1 - IT(AR3), DBS Lead Insertion Tube with Stylet - 239.85mm length, 1.83mm od, 1.60mm id2 - Insertion Tube Extractors

Device Class : 1

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAO, HAW

Prescription Use : Yes

Device Count : 1