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 Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive 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

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• 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