microTargeting™ WayPoint™ Inserter Kit 66-WP-ID-03

GUDID 00873263009192

microTargeting WayPoint Inserter Kit, 120mm, without Drape Support

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263009192
• NIH Device Record Key: bf52e5a8-c4de-4501-9834-ad5640b47d84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ WayPoint™ Inserter Kit
• Version Model Number: 66-WP-ID-03-00919
• Catalog Number: 66-WP-ID-03
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263009192 [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

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

[00873263009192]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [microTargeting™ WayPoint™ Inserter Kit]

• 00873263005323: microTargeting WayPoint Inserter Kit, Extended Clearance, 120mm for use with 66-WP-MR kit and mi
• 00873263003367: microTargeting WayPoint Inserter Kit, 130mm, for use with 66-WP-MR kit and microTargeting Platfo
• 00873263003336: microTargeting WayPoint Inserter Kit, 120mm for use with 66-WP-MR kit and microTargeting Platfor
• 00873263009192: microTargeting WayPoint Inserter Kit, 120mm, without Drape Support