WayPoint™ Combination Driver Bit 66-WP-CD-01

GUDID 00873263003206

WayPoint Combination Driver Bit with Collar

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

• Primary Device ID: 00873263003206
• NIH Device Record Key: a89b75be-9161-47cf-8fd2-e4b0170818d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Combination Driver Bit
• Version Model Number: 66-WP-CD-01-00320
• Catalog Number: 66-WP-CD-01
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003206 [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

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003206]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-05
• Device Publish Date: 2016-09-17

On-Brand Devices [WayPoint™ Combination Driver Bit]

• 00873263003206: WayPoint Combination Driver Bit with Collar
• 00873263003183: WayPoint Combination Driver Bit