WayPoint™ Target Offset Mounting Hub 66-MP-TH

GUDID 00873263007259

WayPoint Target Offset Mounting Hub, 6mm offset, for use with microTargeting Platform

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263007259
• NIH Device Record Key: ddf6c465-2479-409d-b02a-7e5ab3d38b4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Target Offset Mounting Hub
• Version Model Number: 66-MP-TH-00724
• Catalog Number: 66-MP-TH
• 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: true
• 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
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

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
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• 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	00873263007242 [Primary]
GS1	00873263007259 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092562

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

[00873263007259]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-18
• Device Publish Date: 2018-12-18

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

• 00873263007259: WayPoint Target Offset Mounting Hub, 6mm offset, for use with microTargeting Platform
• 00873263001714: WayPoint Target Offset Mounting Hub, 6mm offset, for use with microTargeting Platform
• 00873263007242: WayPoint Target Offset Mounting Hub, 6mm offset, for use with microTargeting Platform