microTargeting™ Electrode MTDWZP(SP)(AR5)

GUDID 10873263004729

microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile

FHC, INC.

Depth electrode

• Primary Device ID: 10873263004729
• NIH Device Record Key: 0b3537ae-fa29-4a22-8acf-89129e54478e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrode
• Version Model Number: MTDWZP(SP)(AR5)-00472
• Catalog Number: MTDWZP(SP)(AR5)
• 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

• Length: 276.5 Millimeter
• Length: 276.5 Millimeter
• Length: 276.5 Millimeter
• Length: 276.5 Millimeter
• Length: 276.5 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263004722 [Primary]
GS1	10873263004729 [Package]; Contains: 00873263004722; 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

[10873263004729]

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

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• 10873263003418: microTargeting Electrode, differential, platinum/iridium, glass insulated, specify Z, sterile
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