Sonon 300L

GUDID 00860000879835

System, Imaging, Pulsed Doppler, Ultrasonic

Healcerion Co., Ltd.

Extracorporeal ultrasound imaging transducer, mounted

• Primary Device ID: 00860000879835
• NIH Device Record Key: 808ce641-27f0-4693-8fbc-704b795332af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonon
• Version Model Number: 300L
• Catalog Number: 300L
• Company DUNS: 688732988
• Company Name: Healcerion Co., Ltd.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000879835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170085

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2019-02-21
• Device Publish Date: 2019-01-21

On-Brand Devices [Sonon]

• 00860000879842: System, Imaging, Pulsed Echo, Ultrasonic
• 00860000879835: System, Imaging, Pulsed Doppler, Ultrasonic
• 00860000879811: System, Imaging, Pulse Echo, Ultrasonics
• 00860000879804: Transducer, Ultrasonic, Diagnostic