microTargeting™ Electrode FC1002

GUDID 10873263007478

microTargeting Electrode 5x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive

FHC, INC.

Depth electrode

• Primary Device ID: 10873263007478
• NIH Device Record Key: e6d11994-7265-48de-b544-abeaed8300e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrode
• Version Model Number: FC1002-00747
• Catalog Number: FC1002
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 5
• 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: 271.4 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007471 [Unit of Use]
GS1	10873263007478 [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

[10873263007478]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-27

On-Brand Devices [microTargeting™ Electrode]

• 10873263006723: microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation, Presterile
• 10873263006693: microTargeting™ Electrode, back loaded, presterile, tungsten
• 10873263006617: microTargeting™ Electrodes, differential, tungsten, sterile, DZAP
• 10873263006594: microTargeting™ Electrodes, differential, tungsten, sterile, LZAP
• 10873263006518: microTargeting™ Electrode, differential, sterile, platinum/iridium
• 10873263006426: microTargeting(TM) Electrode, sterile, D.ZAP(Z), for use with Platform
• 10873263006402: microTargeting(TM) Electrode, sterile, 5x, D.ZAP(L), for use with Platform
• 10873263005788: microTargeting(TM) Electrode, sterile, for use with Nexframe(R) and STar Drive
• 10873263005740: microTargeting(TM) Electrode, sterile, for use with Nexframe(R)
• 10873263005429: microTargeting(TM) Electrode, differential, tungsten, sterile
• 10873263005382: microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), sterile
• 10873263005191: microTargeting Electrode, side by side, tungsten, DZAP(L), sterile
• 10873263005047: microTargeting(TM) Electrode, array, differential, 1 Meg, sterile, for Nexframe
• 10873263004927: microTargeting(TM) Electrode, shielded, tungsten, DZAP(L), sterile
• 10873263004903: microTargeting(TM) Electrode, shielded, tungsten, sterile
• 10873263004729: microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
• 10873263004668: microTargeting Electrode, differential, tungsten, DZAP(Z), sterile
• 10873263004644: microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
• 10873263004620: microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
• 10873263004590: microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
• 10873263004569: microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
• 10873263004545: microTargeting Electrode, differential, tungsten, DZAP(Z), sterile
• 10873263004521: microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
• 10873263004507: microTargeting(TM) Electrode, 5x, differential, tungsten, DZAP(Z), sterile
• 10873263004484: microTargeting(TM) Electrode, 5x, differential, tungsten, DZAP(Z), sterile
• 10873263004026: microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), sterile
• 10873263004002: microTargeting(TM) Electrode, differential, tungsten, sterile, DZAP(L)
• 10873263003982: microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), sterile
• 10873263003906: microTargeting(TM) Electrode, differential, tungsten, sterile
• 10873263003883: microTargeting(TM) Electrode, differential, tungsten, sterile
• 10873263003586: microTargeting(TM) Electrode, differential, platinum/iridium, epoxylite insulated, sterile, D.ZA
• 10873263003487: microTargeting(TM) Electrode, differential, platinum/iridium, epoxylite insulated, sterile, D.ZA
• 10873263003456: microTargeting(TM) Electrode, differential, platinum/iridium, epoxy insulated, sterile, D.ZAP(Z)
• 10873263003418: microTargeting Electrode, differential, platinum/iridium, glass insulated, specify Z, sterile
• 10873263003395: microTargeting(TM) Electrode, differential, platinum/iridium, glass insulated, specify Z, steril
• 10873263003265: microTargeting(TM) Electrode, differential, sterile, platinum/iridium, glass insulated
• 10873263003258: microTargeting(TM) Electrode, differential, platinum/iridium, sterile
• 10873263003227: microTargeting(TM) Electrode, differential, sterile, platinum/iridium, glass insulated
• 10873263003098: microTargeting(TM) Electrode, backloaded, tungsten, sterile
• 10873263002893: microTargeting(TM) Electrode, sterile, D.ZAP(Z), for Nexframe(R) and STar(R) Drive
• 10873263002831: microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Nexframe(R) and STar Drive
• 10873263002770: microTargeting(TM) Electrode, sterile, D.ZAP(Z), for use with Nexframe(R)
• 10873263002732: microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Nexframe(R)
• 10873263002671: microTargeting(TM) Electrode, sterile, D.Zap(Z), for use with Platform
• 10873263002633: microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Platform
• 10873263002596: microTargeting(TM) Electrode, 1x, sterile, R.ZAP, Platform
• 10873263002541: microTargeting(TM) Electrode, 1x, sterile, single, D.ZAP(Z), T=30 for use with Frame and STar or
• 10873263002527: microTargeting(TM) Electrode, sterile, single, D.ZAP(L), T=30 for use with Frame and STar or MT
• 10873263002503: microTargeting(TM) Electrode, differential, sterile, single, 1 Meg for use with Frame and STar o
• 10873263002442: microTargeting Array Electrode, 1x, sterile, D.ZAP(L) for use with Frame, STar or MT Drive