microTargeting™ Electrodes FC2004

GUDID 10873263007522

microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive

FHC, INC.

Depth electrode

• Primary Device ID: 10873263007522
• NIH Device Record Key: 4ef414c2-7819-40c8-b357-bfad356e0d08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrodes
• Version Model Number: FC2004-00752
• Catalog Number: FC2004
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007525 [Unit of Use]
GS1	10873263007522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033173

FDA Product Code

• GZL: ELECTRODE, DEPTH

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10873263007522]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-08
• Device Publish Date: 2019-12-31

On-Brand Devices [microTargeting™ Electrodes]

• 10873263001292: microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with
• 10873263001179: microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT
• 10873263007553: microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT
• 10873263007522: microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with