SOFRA1L

GUDID 08800076600034

FCU

Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 08800076600034
• NIH Device Record Key: 4ddee04f-78b7-4854-9037-9314e295fbb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFRA1L
• Version Model Number: SC1
• Company DUNS: 689841519
• Company Name: FCU
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800076600034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210468

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: 2021-11-08
• Device Publish Date: 2021-10-29

Devices Manufactured by FCU

• 08800076600119 - SC1: 2021-11-09
• 08800076600133 - Sono Champion: 2021-11-09
• 08800076600140 - Sono Changer: 2021-11-09
• 08800076600157 - Sono dot AI: 2021-11-09
• 08800076600010 - eZono1000: 2021-11-08
• 08800076600027 - Sonovation1L: 2021-11-08
• 08800076600034 - SOFRA1L: 2021-11-08
• 08800076600034 - SOFRA1L: 2021-11-08
• 08800076600041 - SonoInfra1L: 2021-11-08