microTargeting™ Array Electrode 22675Z

GUDID 10873263002466

microTargeting(TM) Electrode, sterile, 1x, array, D.ZAP(Z) for use with Frame and STar or MT Drive

FHC, INC.

Depth electrode

• Primary Device ID: 10873263002466
• NIH Device Record Key: a69300ef-fb76-4d90-bc6a-56540a07aebb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Array Electrode
• Version Model Number: 22675Z-00246
• Catalog Number: 22675Z
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263002469 [Primary]
GS1	10873263002466 [Package]; Contains: 00873263002469; Package: PK/5 [5 Units]; In Commercial Distribution

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

[10873263002466]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2016-09-17

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