microTargeting™ Platform C0284

GUDID 00873263008478

Entry Offset Positioner (2mm I.D.)

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263008478
• NIH Device Record Key: bc68424f-98af-4f15-a0fb-e2bbf98d8412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Platform
• Version Model Number: C0284-00847
• Catalog Number: C0284
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092192

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

[00873263008478]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-05
• Device Publish Date: 2021-10-28

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• 10873263005924: microTargeting Staged Bilateral Platforms, nonsterile, patient specific
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• 00873263008478: Entry Offset Positioner (2mm I.D.)
• 00873263008461: Center Positioner (2mm I.D.)
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• 00873263008522: microTargeting™ Platform Shaving Template