microTargeting™ Platform Adapter Kit 66-FA-SF

GUDID 00873263001660

microTargeting Platform Drive Adapter Kit

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263001660
• NIH Device Record Key: b48c5ee1-f584-4500-8bad-e4ef02d33fb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Platform Adapter Kit
• Version Model Number: 66-FA-SF-00295
• Catalog Number: 66-FA-SF
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001660 [Direct Marking]
GS1	00873263002957 [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

[00873263001660]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

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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