Hand Piece Electrode SMART

GUDID 08809495931316

Chungwoo Co., Ltd.

Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 08809495931316
• NIH Device Record Key: e0c2fc33-820e-40e4-a6bb-93805e4ac382
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hand Piece Electrode SMART
• Version Model Number: AE20-180
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809495931316 [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

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

Moist Heat or Steam Sterilization

[08809495931316]

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

Devices Manufactured by Chungwoo Co., Ltd.

• 08809495931309 - Hand Piece Electrode LIFT: 2024-09-09
• 08809495931316 - Hand Piece Electrode SMART: 2024-09-09
• 08809495931316 - Hand Piece Electrode SMART: 2024-09-09
• 08809495931323 - Hand Piece Electrode LIPO: 2024-09-09
• 08809495931330 - Electrode LIFT: 2024-09-09
• 08809495931347 - Electrode SMART: 2024-09-09
• 08809495931354 - Electrode LIPO: 2024-09-09
• 08809495931361 - Hand Piece LIFT: 2024-09-09
• 08809495931378 - Hand Piece SMART: 2024-09-09