FHC, INC.

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

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Filters

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) (9) INSTRUMENT, SURGICAL, NON-POWERED (HAO) (1)

Premarket Exempt

No Yes

Clear

STar™ Drive XL Frame Adapter - 00873263002285 Catalog Number : 70-FA-LX-XL

Device Description : XL STar(TM) Leksell Stereotactic System(R) Adapter

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

STar™ Drive Frame Adapter - 00873263002292 Catalog Number : 70-FA-LX-01

Device Description : STar(TM) Drive Offseting Frame Adapter for use with Leksell Stereotactic Frame

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

microTargeting™ STar™ Insertion Tube - 00873263002308 Catalog Number : 70-IT-AR5P

Device Description : microTargeting STar Array Electrode Insertion Tube with Stylet, Sterile, for use

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

microTargeting™ Insertion Tube - 00873263002315 Catalog Number : 70-IT-7147LI

Device Description : microTargeting Lead Insertion Tube with Stylet, Sterile, for use with Nexframe a

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

STar™ Drive Frame Adapter - 00873263002322 Catalog Number : 70-FA-LX

Device Description : STar(TM) Drive Frame Adapter for use with Leksell Stereotactic Frame

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

microTargeting™ STar™ Insertion Tube Set - 00873263002339 Catalog Number : 70-IT-7107

Device Description : microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Ne

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

microTargeting™ STar™ Inerstion Tube Set - 00873263002346 Catalog Number : 70-IT-3007

Device Description : microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Ne

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

STar™ Drive Frame Adapter - 00873263002353 Catalog Number : 70-FA-BL

Device Description : STar(TM) Drive Frame Adapter for use with Brain Lab(R)/Micromar stereotactic frames

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

microTargeting™ STar™ Array Insertion Tube Extractor - 00873263002360 Catalog Number : 70-CN-ET

Device Description : microTargeting STar Array Insertion Tube Extractor, 5x, Sterile, for use the STa

Device Class : 1

Duns Number: 108179458

Premarket Exempt : Yes

Product Code : HAO

Prescription Use : Yes

Device Count : 1

microTargeting™ Stylet - 00873263002377 Catalog Number : 66-ST-14P

Device Description : microTargeting DP Stylet, 1x, nonsterile, for use with mT Drive and STar Drive

Device Class : 2

Duns Number: 108179458

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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