SABERWAVE/ECO Microwave therapeutic system

GUDID 06972405777006

The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that deliver the microwave energy at a working frequency of 2450 MHz.

ECO Medical Technology (Nanjing) Co., Ltd.

Microwave ablation system generator

• Primary Device ID: 06972405777006
• NIH Device Record Key: ecb5b1c6-9c53-4e96-819a-9c42c22e50b8
• Commercial Distribution Discontinuation: 2022-12-02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SABERWAVE/ECO Microwave therapeutic system
• Version Model Number: SABERWAVE ECO-200G
• Company DUNS: 546257098
• Company Name: ECO Medical Technology (Nanjing) 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: false
• 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	06972405777006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201262

FDA Product Code

• NEY: System, Ablation, Microwave And 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: 2022-11-10
• Device Publish Date: 2022-11-02

Devices Manufactured by ECO Medical Technology (Nanjing) Co., Ltd.

• 06972405777006 - SABERWAVE/ECO Microwave therapeutic system: 2022-11-10The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that deliver the microwave energy at a working frequency of 2450 MHz.
• 06972405777006 - SABERWAVE/ECO Microwave therapeutic system: 2022-11-10 The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system
• 06972405777013 - ECO Disposable microwave therapeutic antenna: 2022-11-10 Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with cooling tubes.
• 06972405777020 - ECO Disposable microwave therapeutic antenna: 2022-11-10 Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with cooling tubes.
• 06972405777037 - ECO Disposable microwave therapeutic antenna: 2022-11-10 Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with cooling tubes.
• 06972405777044 - ECO Disposable microwave therapeutic antenna: 2022-11-10 Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with cooling tubes.
• 06972405777051 - ECO Disposable microwave therapeutic antenna: 2022-11-10 Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with cooling tubes.
• 06972405777068 - ECO Disposable microwave therapeutic antenna: 2022-11-10 Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with cooling tubes.
• 06972405777075 - ECO Disposable microwave therapeutic antenna: 2022-11-10 Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with cooling tubes.