microTargeting™ Platform MP-KIT-P-SB

GUDID 10873263004231

microTargeting Staged Bilateral Platforms, nonsterile, patient customized

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 10873263004231
• NIH Device Record Key: a88ba93d-754c-4137-8b47-6c341d02ac81
• Commercial Distribution Discontinuation: 2019-06-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: microTargeting™ Platform
• Version Model Number: MP-KIT-P-SB-00423
• Catalog Number: MP-KIT-P-SB
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 2
• 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: false
• Serial Number: true
• 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 Temperature: Between -34 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263004234 [Unit of Use]
GS1	10873263004231 [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

[10873263004231]

Ethylene Oxide;Hydrogen Peroxide;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]

• 00873263004258: microTargeting Four Legged Unilateral Platform, 1x, nonsterile. Patient customized.
• 00873263004241: microTargeting Three Legged Unilateral Platform, 1x, nonsterile. Patient customized.
• 00873263004180: microTargeting Epilepsy Platform, Multi-Oblique, 1x, nonsterile
• 00873263004173: microTargeting Epilepsy Platform, orthogonal - oblique, 1x, nonsterile
• 00873263004166: Bilateral Platform, patient customized
• 00873263001813: microTargeting, Multi-Oblique, Single Trajectory Platform, 1x, nonsterile
• 00873263001806: microTargeting Multi-Oblique Dual Trajectory Platform, 1x, nonsterile
• 10873263004231: microTargeting Staged Bilateral Platforms, nonsterile, patient customized
• 10873263005924: microTargeting Staged Bilateral Platforms, nonsterile, patient specific
• 00873263005989: microTargeting Multi-Oblique Dual Trajectory Platform, 1x, nonsterile
• 00873263005972: microTargeting, Multi-Oblique, Single Trajectory Platform, 1x, nonsterile
• 00873263005965: microTargeting Epilepsy Platform, Multi-Oblique, 1x, nonsterile
• 00873263005941: microTargeting Four Legged Unilateral Platform, 1x, nonsterile. Patient specific.
• 00873263005934: microTargeting Three Legged Unilateral Platform, 1x, nonsterile. Patient specific.
• 00873263005910: microTargeting Epilepsy Platform, orthogonal - oblique, 1x, nonsterile
• 00873263005903: Bilateral Platform, patient specific
• 00873263008126: microTargeting™ Ablation Platform, 1x
• 00873263008478: Entry Offset Positioner (2mm I.D.)
• 00873263008461: Center Positioner (2mm I.D.)
• 00873263008430: Six-Trajectory Bilateral Platform
• 00873263008522: microTargeting™ Platform Shaving Template