Dophi

GUDID 16972304750077

Radio Frequency Electrode Kits

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Radio-frequency ablation system

• Primary Device ID: 16972304750077
• NIH Device Record Key: b2e823c7-e769-42e7-a953-956e289fac8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dophi
• Version Model Number: SS-RFAS1-2030
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16972304750077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190052

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: 2022-03-15
• Device Publish Date: 2022-03-07

On-Brand Devices [Dophi]

• 16972304750282: Microwave Ablation Electrode Kits
• 16972304750275: Microwave Ablation Electrode Kits
• 16972304750268: Microwave Ablation Electrode Kits
• 16972304750251: Microwave Ablation Electrode Kits
• 16972304750244: Microwave Ablation Electrode Kits
• 16972304750237: Microwave Ablation Electrode Kits
• 16972304750015: Temperature Probe
• 06972304751435: Foot Switch
• 06972304750292: Microwave Ablaton Generator
• 16972304750190: Radio Frequency Electrode Kits
• 16972304750183: Radio Frequency Electrode Kits
• 16972304750176: Radio Frequency Electrode Kits
• 16972304750169: Radio Frequency Electrode Kits
• 16972304750152: Radio Frequency Electrode Kits
• 16972304750145: Radio Frequency Electrode Kits
• 16972304750138: Radio Frequency Electrode Kits
• 16972304750121: Radio Frequency Electrode Kits
• 16972304750114: Radio Frequency Electrode Kits
• 16972304750107: Radio Frequency Electrode Kits
• 16972304750091: Radio Frequency Electrode Kits
• 16972304750084: Radio Frequency Electrode Kits
• 16972304750077: Radio Frequency Electrode Kits
• 16972304750060: Radio Frequency Electrode Kits
• 16972304750053: Radio Frequency Electrode Kits
• 16972304750046: Radio Frequency Electrode Kits
• 16972304750039: Radio Frequency Electrode Kits
• 16972304750022: Radio Frequency Electrode Kits
• 06972304751411: Foot Switch
• 06972304750209: Radio Frequency Generator