Electrode SMART

GUDID 08809495931347

Chungwoo Co., Ltd.

Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 08809495931347
• NIH Device Record Key: a0d2ca2a-e1d1-40b8-a717-febf85621298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrode SMART
• Version Model Number: 2X180
• Company DUNS: 689894533
• Company Name: Chungwoo 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr
• Phone: +8207052091112
• Email: cwqc@mycw.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809495931347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222709

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

[08809495931347]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-09
• Device Publish Date: 2024-08-30

On-Brand Devices [Electrode SMART]

• 08809495931170: AE20-180
• 08809495931347: 2X180