microTargeting™ Platform Accessory MP-KIT-A-PS

GUDID 00873263008447

Six-Trajectory Bilateral Platform Phantom

FHC, INC.

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

On-Brand Devices [microTargeting™ Platform Accessory]

• 00873263005392: microTargeting Epilepsy Grid, Small. For use with Epilepsy Orthogonal - Oblique Platform.
• 00873263005378: microTargeting Epilepsy Grid, Large. For use with Epilepsy Orthogonal - Oblique Platform
• 00873263004159: Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
• 00873263004142: Peek Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform
• 00873263004135: Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
• 00873263004081: Stainless Steel Mounting Thumbknobs, nonsterile. For use with microTargeting Platform
• 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.