Radio Frequency System

GUDID 06976264730073

SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD

Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: 06976264730073
• NIH Device Record Key: 9e17f6df-1061-4e39-bbe6-8ec0ba72bfc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radio Frequency System
• Version Model Number: RF-301
• Company DUNS: 706040997
• Company Name: SHENZHENSHI SINCOHEREN S&T DEVELOPMENT 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976264730073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231749

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: 2023-11-27
• Device Publish Date: 2023-11-17

Devices Manufactured by SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD

• 06976264730028 - LED Spectrum therapy instrument: 2023-11-27
• 06976264730035 - LED Spectrum therapy instrument: 2023-11-27
• 06976264730042 - LED Spectrum therapy instrument: 2023-11-27
• 06976264730059 - LED Spectrum therapy instrument: 2023-11-27
• 06976264730066 - LED Spectrum therapy instrument: 2023-11-27
• 06976264730073 - Radio Frequency System: 2023-11-27
• 06976264730073 - Radio Frequency System: 2023-11-27
• 06976264730080 - Microneedle electrodes: 2023-11-27
• 06976264730097 - Microneedle electrodes: 2023-11-27