microTargeting™ Platform Accessory MP-KIT-A-SG

GUDID 00873263005392

microTargeting Epilepsy Grid, Small. For use with Epilepsy Orthogonal - Oblique Platform.

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263005392
• NIH Device Record Key: 29c5f7c7-7755-49c1-a4c3-8a9c6933d017
• Commercial Distribution Discontinuation: 2019-06-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: microTargeting™ Platform Accessory
• Version Model Number: MP-KIT-A-SG-00539
• Catalog Number: MP-KIT-A-SG
• 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: 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263005392 [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

[00873263005392]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-24
• Device Publish Date: 2016-09-17

On-Brand Devices [microTargeting™ Platform Accessory]

• 00873263005392: microTargeting Epilepsy Grid, Small. For use with Epilepsy Orthogonal - Oblique Platform.
• 00873263005378: microTargeting Epilepsy Grid, Large. For use with Epilepsy Orthogonal - Oblique Platform
• 00873263004159: Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
• 00873263004142: Peek Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform
• 00873263004135: Stainless Steel Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform.
• 00873263004081: Stainless Steel Mounting Thumbknobs, nonsterile. For use with microTargeting Platform
• 00873263003794: Customized Phantom, for use with microTargeting Platform
• 00873263003671: Peek Thumb-Knobs, nonsterile, for use with microTargeting Platform
• 00873263006009: microTargeting Epilepsy Grid, Large. For use with Epilepsy Orthogonal - Oblique Platform
• 00873263005996: microTargeting Epilepsy Grid, Small. For use with Epilepsy Orthogonal - Oblique Platform.
• 00873263005958: Patient specific Phantom, for use with microTargeting Platform
• 10873263006259: Stainless Steel Mounting Thumbknobs, Nonsterile, 50X. For use with microTargeting Platform
• 00873263008447: Six-Trajectory Bilateral Platform Phantom
• 10873263006266: Stainless Steel Thumbknobs, nonsterile, 50X. For use with microTargeting Platform.