microTargeting™ Platform Accessory MP-KIT-A-PS

GUDID 00873263008447

Six-Trajectory Bilateral Platform Phantom

FHC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00873263008447
• NIH Device Record Key: af1170ec-abc2-40eb-8bd6-8dd026283861
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Platform Accessory
• Version Model Number: MP-KIT-A-PS-00844
• Catalog Number: MP-KIT-A-PS
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008447 [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

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

[00873263008447]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-05
• Device Publish Date: 2021-10-28

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• 00873263004135: Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
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• 00873263003794: Customized Phantom, for use with microTargeting Platform
• 00873263003671: Peek Thumb-Knobs, nonsterile, for use with microTargeting Platform
• 00873263006009: microTargeting Epilepsy Grid, Large. For use with Epilepsy Orthogonal - Oblique Platform
• 00873263005996: microTargeting Epilepsy Grid, Small. For use with Epilepsy Orthogonal - Oblique Platform.
• 00873263005958: Patient specific Phantom, for use with microTargeting Platform
• 10873263006259: Stainless Steel Mounting Thumbknobs, Nonsterile, 50X. For use with microTargeting Platform
• 00873263008447: Six-Trajectory Bilateral Platform Phantom
• 10873263006266: Stainless Steel Thumbknobs, nonsterile, 50X. For use with microTargeting Platform.