microTargeting™ Differential Electrode MTDWZN(AR)(DU1)

GUDID 10873263007065

microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile

FHC, INC.

Depth electrode

• Primary Device ID: 10873263007065
• NIH Device Record Key: 416d37eb-ff5f-4e54-8d6e-57152cedf6e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Differential Electrode
• Version Model Number: MTDWZN(AR)(DU1)-00706
• Catalog Number: MTDWZN(AR)(DU1)
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 6
• DM Exempt: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007068 [Unit of Use]
GS1	10873263007065 [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

[10873263007065]

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: 2018-10-30

On-Brand Devices [microTargeting™ Differential Electrode]

• 10873263007072: microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
• 10873263007065: microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile