microTargeting™ Electrodes FC5000

GUDID 10873263007553

microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.

FHC, INC.

Depth electrode

• Primary Device ID: 10873263007553
• NIH Device Record Key: 426f8dd2-17a7-4f0f-a645-f4ae1fe6db25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrodes
• Version Model Number: FC5000-00755
• Catalog Number: FC5000
• 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

• Length: 249.2 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007556 [Unit of Use]
GS1	10873263007553 [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

[10873263007553]

Moist Heat or Steam Sterilization;Ethylene Oxide

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