PreOp

GUDID 05430000733007

PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.

Epilog

Bioelectrical signal analysis software

• Primary Device ID: 05430000733007
• NIH Device Record Key: 3418ece6-9e32-468c-a8b1-acfaa1df9857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreOp
• Version Model Number: 1.0.0
• Company DUNS: 371461292
• Company Name: Epilog
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• 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) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care
• Phone: +1 (800) 687-0416
• Email: info@epilog.care

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430000733007 [Primary]

FDA Product Code

• OLX: Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-09
• Device Publish Date: 2020-10-01

On-Brand Devices [PreOp ]

• 05430000733007: PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and
• 05430000733021: PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technolo