WayPoint™ Pilot Drill 66-WP-PD

GUDID 00873263003473

microTargeting WayPoint 1.1mm Pilot Drill Bit, 1x, nonsterile

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263003473
• NIH Device Record Key: a766116e-5bb2-459b-b784-7209f28a70fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Pilot Drill
• Version Model Number: 66-WP-PD-00347
• Catalog Number: 66-WP-PD
• 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: true
• 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

Device Dimensions

• Outer Diameter: 1.1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003473 [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

[00873263003473]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-07
• Device Publish Date: 2016-09-17

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