Dophi

GUDID 16972304750237

Microwave Ablation Electrode Kits

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered

• Primary Device ID: 16972304750237
• NIH Device Record Key: c02d84d6-f756-44a9-948d-02c60d597018
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dophi
• Version Model Number: SS-MWA-2531C
• 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	16972304750237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183153

FDA Product Code

• NEY: System, Ablation, Microwave And 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: 2022-01-27
• Device Publish Date: 2022-01-19

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