microTargeting™ Sterile Drape Sleeves FC1004

GUDID 10873263001414

microTargeting Sterile Drape Sleeves 20x, for use with STar and MT Drives with motor or encoder option.

FHC, INC.

Patient surgical drape, single-use

• Primary Device ID: 10873263001414
• NIH Device Record Key: 53827fcf-7a41-43af-9d52-e489d4c23d4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Sterile Drape Sleeves
• Version Model Number: FC1004-00141
• Catalog Number: FC1004
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001417 [Unit of Use]
GS1	10873263001414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011992

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

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Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

[10873263001414]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-08-22

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• 00873263009253 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, non-sterile, D.ZAP(Z)
• 00873263009222 - STarFix™ Designer: 2024-07-22 STarFix™ Designer DBS
• 00873263002155 - STar™ Drive M/E: 2024-05-22 STar(TM) Drive ME, Motor/Encoder Version
• 00873263002162 - STar™ Drive MA: 2024-05-22 STar(TM) Drive MA, Manual Operation Only