Microneedle electrodes

GUDID 06976264730080

SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 06976264730080
• NIH Device Record Key: aeab31f0-e1c5-478a-8149-2adb790a902f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microneedle electrodes
• Version Model Number: 25-Pin
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	06976264730080 [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: true

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

On-Brand Devices [Microneedle electrodes]

• 06976264730097: 49-Pin
• 06976264730080: 25-Pin