FHC, INC.

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Neurological stereotaxic Instrument (HAW) (10)

Premarket Exempt

No Yes

Clear

microTargeting™ Accessories Kit - 00873263000199 Catalog Number : FC1017

Device Description : Accesories Kit for microTargeting Drive

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

microTargeting™ Array Electrode Carrier and Clamp - 00873263000618 Catalog Number : FC1021

Device Description : Array Electrode Carrier and Clamp for microTargeting(TM) Drive

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

STar™ Drive Electrode Carrier - 00873263000830 Catalog Number : FC8008

Device Description : STar(TM) Drive Locking Array Electrode Carrier

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

microTargeting™ Frame Adapter - 00873263001035 Catalog Number : FC1009

Device Description : Radionics CRW Frame Adapter for use with microTargeting Drive

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

microTargeting™ Frame Adapter - 00873263001042 Catalog Number : FC1010

Device Description : Leksell Stereotactic Frame Adapter for use with microTargeting Drive

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

STar™ Drive Frame Adapter - 00873263001059 Catalog Number : FC8003

Device Description : STar(TM) Drive Frame Adapter for use with Leskell stereotactic frame

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

STar™ Drive Frame Adapter - 00873263001066 Catalog Number : FC8004

Device Description : STar(TM) Drive Frame Adapter for use with Radionics CRW stereotactic frame

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

STar™ Drive Frame Adapter - 00873263001073 Catalog Number : FC8005

Device Description : STar(TM) Drive Frame Adapter for use with Leibinger RM stereotactic frame

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

STar™ Drive Frame Adapter - 00873263001080 Catalog Number : FC8006

Device Description : STar(TM) Drive Frame Adapter for use with Leibinger ZD stereotactic frame

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

microTargeting™ Insertion Tube Set - 00873263001301 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

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