WayPoint™ Multi-Oblique Tool Guide 66-MO-05

GUDID 00873263005507

WayPoint Multi-Oblique Platform 2.5mm Tool Guide

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263005507
• NIH Device Record Key: 43ebd335-f6a2-44c0-b172-68db1faf0750
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Multi-Oblique Tool Guide
• Version Model Number: 66-MO-05-00550
• Catalog Number: 66-MO-05
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Dimensions

• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263005507 [Primary]
GS1	00873263007167 [Direct Marking]

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

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

[00873263005507]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-29
• Device Publish Date: 2016-11-07

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