Sonicure

GUDID 06972304750315

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system Soft-tissue ultrasonic surgical system

• Primary Device ID: 06972304750315
• NIH Device Record Key: 6d15e18f-38d6-4aa2-83c5-e32ffeb3b15a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonicure
• Version Model Number: SC100E
• Company DUNS: 550274579
• Company Name: Surgnova Healthcare Technologies (Zhejiang) 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	06972304750315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212614

FDA Product Code

• LFL: Instrument, Ultrasonic Surgical

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: 2022-11-03
• Device Publish Date: 2022-10-26

On-Brand Devices [Sonicure]

• 16972304752828: TG-A
• 16972304750480: SC43C+
• 16972304750473: SC35C+
• 16972304750466: SC21C+
• 16972304750459: SC13C+
• 16972304750329: SC100T
• 06972304750315: SC100E