microTargeting™ Electrode 44930R

GUDID 10873263005726

microTargeting(TM) Electrode, 6x, non-sterile, single, for use with Platform

FHC, INC.

Depth electrode

• Primary Device ID: 10873263005726
• NIH Device Record Key: e856ea57-6db2-44f9-9a1c-c3f7739cdd2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrode
• Version Model Number: 44930R-00572
• Catalog Number: 44930R
• 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

• Length: 205.7 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263005729 [Unit of Use]
GS1	10873263005726 [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

[10873263005726]

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: 2017-03-03

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