microTargeting™ Platform NeuroBlate® Adaptor Kit 66-WP-NB

GUDID 00873263006016

microTargeting Platform NeuroBlate Adaptor Kit, nonsterile, for use with STarFix Surgical Kit and Monteris NeuroBlate System. Contains: Monteris NeuroBlate Center Positioner Center Hub Target Offset Hub Entry Offset Hub

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263006016
• NIH Device Record Key: 44b846de-8ef0-4dce-aa69-c349b898cfd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Platform NeuroBlate® Adaptor Kit
• Version Model Number: 66-WP-NB-00601
• Catalog Number: 66-WP-NB
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263006016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092192

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263006016]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-01
• Device Publish Date: 2019-06-21

On-Brand Devices [microTargeting™ Platform NeuroBlate® Adaptor Kit]

• 00873263003442: microTargeting Platform NeuroBlate Adaptor Kit, nonsterile, for use with STarFix Surgical Kit an
• 00873263006016: microTargeting Platform NeuroBlate Adaptor Kit, nonsterile, for use with STarFix Surgical Kit an