microTargeting™ WayPoint™ Inserter Kit 66-WP-ID

GUDID 00873263003336

microTargeting WayPoint Inserter Kit, 120mm for use with 66-WP-MR kit and microTargeting Platform

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263003336
• NIH Device Record Key: 7755c69f-91fd-4656-8532-7f0ef797de97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ WayPoint™ Inserter Kit
• Version Model Number: 66-WP-ID-00333
• Catalog Number: 66-WP-ID
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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

• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 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
• 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	00873263003336 [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

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

[00873263003336]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [microTargeting™ WayPoint™ Inserter Kit]

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• 00873263003367: microTargeting WayPoint Inserter Kit, 130mm, for use with 66-WP-MR kit and microTargeting Platfo
• 00873263003336: microTargeting WayPoint Inserter Kit, 120mm for use with 66-WP-MR kit and microTargeting Platfor
• 00873263009192: microTargeting WayPoint Inserter Kit, 120mm, without Drape Support