WayPoint™ Indexing Ring 66-MP-IR

GUDID 00873263003039

WayPoint Indexing Ring for use with microTargeting Platform

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263003039
• NIH Device Record Key: 94fc2cc4-a31b-4f23-94fc-c02f72bab0b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Indexing Ring
• Version Model Number: 66-MP-IR-00303
• Catalog Number: 66-MP-IR
• 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: 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
• 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	00873263003039 [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

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263003039]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

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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