VIVACE Electrosurgical System

GUDID 08800017100463

shenb Co., Ltd.

Radio-frequency skin surface treatment system

• Primary Device ID: 08800017100463
• NIH Device Record Key: fb67e17c-8793-46c1-96e6-b2887945e604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVACE Electrosurgical System
• Version Model Number: VIVACE
• Company DUNS: 690425442
• Company Name: shenb 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	08800017100463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193070

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: 2021-06-28
• Device Publish Date: 2021-06-18

On-Brand Devices [VIVACE Electrosurgical System]

• 08800017100326: VIVACE
• 08800017100463: VIVACE