Imagio® 8500-185-00

GUDID 00864802000466

US L18-5 Probe

Seno Medical Instruments, Inc.

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00864802000466
• NIH Device Record Key: 68d6d5f1-f07b-402e-a544-784a98e9d5b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imagio®
• Version Model Number: 8500
• Catalog Number: 8500-185-00
• Company DUNS: 615062499
• Company Name: Seno Medical Instruments, Inc.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• 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: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com
• Phone: 888-978-8835
• Email: service@senomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864802000466 [Primary]

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-17
• Device Publish Date: 2023-07-07

On-Brand Devices [Imagio®]

• 00864802000466: US L18-5 Probe
• 00864802000459: Imagio Breast Imaging System Model 9100
• 00864802000442: Transducer (OA/US Probe) Model 8100