microTargeting™ Array Electrode 22335Z

GUDID 10873263007898

microTargeting™ Array Electrodes 6x Non Sterile

FHC, INC.

Depth electrode

• Primary Device ID: 10873263007898
• NIH Device Record Key: 01e9242a-27e5-4f41-8c00-8dbea8467ed8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Array Electrode
• Version Model Number: 22335Z-00789
• Catalog Number: 22335Z
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 6
• 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

• Outer Diameter: 0.55 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007891 [Unit of Use]
GS1	10873263007898 [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: false

[10873263007898]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-23
• Device Publish Date: 2019-08-24

On-Brand Devices [microTargeting™ Array Electrode]

• 10873263002466: microTargeting(TM) Electrode, sterile, 1x, array, D.ZAP(Z) for use with Frame and STar or MT Dri
• 10873263007911: microTargeting™ Array Frame Platinum 6X Non Sterile
• 10873263007898: microTargeting™ Array Electrodes 6x Non Sterile
• 10873263007928: microTargeting™ Array Frame Platinum 5X Sterile
• 10873263007904: microTargeting™ Array Electrodes 5x Sterile