Varicure

GUDID 06972304750681

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator Electrosurgical/ultrasonic surgical system generator

• Primary Device ID: 06972304750681
• NIH Device Record Key: 46fc1c4b-f6a1-43d6-b268-c976f2c8f74e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varicure
• Version Model Number: SC200ES
• 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	06972304750681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210488

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2022-11-04
• Device Publish Date: 2022-10-27

On-Brand Devices [Varicure]

• 06972304750728: ES300
• 06972304750711: ES200
• 06972304750704: ES100
• 06972304750698: SC100ES
• 06972304750681: SC200ES
• 06972304750667: SC300ES