LEAF

GUDID 08809581021778

GCS Co., Ltd.

Thermo-mechanical skin surface treatment system

• Primary Device ID: 08809581021778
• NIH Device Record Key: 2c74fa09-925d-4fd6-9543-a20d7b9dc8dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEAF
• Version Model Number: GFP-2000
• Company DUNS: 688549330
• Company Name: GCS Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809581021778 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

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