Plaxpot Multi Plasma

GUDID 08809581025837

GCS Co., Ltd.

Electrosurgical handpiece, reusable

• Primary Device ID: 08809581025837
• NIH Device Record Key: c46cfd31-7db8-4d0b-8a79-c28b16ee3752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plaxpot Multi Plasma
• Version Model Number: GPX-2000
• Company DUNS: 688549330
• Company Name: GCS 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: true
• 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	08809581025837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220493

FDA Product Code

• QVJ: Low Power Electrosurgical Devices For Skin Lesion Destruction

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: 2024-11-22
• Device Publish Date: 2024-11-14

Devices Manufactured by GCS Co., Ltd.

• 08809581021778 - LEAF: 2024-11-22
• 08809581025837 - Plaxpot Multi Plasma: 2024-11-22
• 08809581025837 - Plaxpot Multi Plasma: 2024-11-22