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

GUDID 00873263003206

WayPoint Combination Driver Bit with Collar

FHC, INC.

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