WayPoint™ Entry Offset Mounting Hub 66-MP-EH

GUDID 00873263001677

WayPoint 3mm Entry Offset Mounting Hub for use with microTargeting Platform

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263001677
• NIH Device Record Key: 9c70a3b0-684e-4e3e-95c7-77850d3db3fb
• Commercial Distribution Discontinuation: 2018-12-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WayPoint™ Entry Offset Mounting Hub
• Version Model Number: 66-MP-EH-00298
• Catalog Number: 66-MP-EH
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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

Device Dimensions

• Length: 3 Millimeter
• Length: 3 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001677 [Direct Marking]
GS1	00873263002988 [Primary]
GS1	00873263006047 [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

[00873263001677]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263001677]

Ethylene Oxide;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: 2018-12-19
• Device Publish Date: 2016-09-17

On-Brand Devices [WayPoint™ Entry Offset Mounting Hub]

• 00873263007273: WayPoint 3mm Entry Offset Mounting Hub for use with microTargeting Platform
• 00873263001677: WayPoint 3mm Entry Offset Mounting Hub for use with microTargeting Platform
• 00873263007266: WayPoint 3mm Entry Offset Mounting Hub for use with microTargeting Platform