OMZ-100

GUDID 08809520341141

GTG Wellness Co., Ltd.

Blue/red/infrared phototherapy lamp

• Primary Device ID: 08809520341141
• NIH Device Record Key: 50009d12-a0bf-490f-a11c-8322f1410b93
• Commercial Distribution Discontinuation: 2023-03-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OMZ-100
• Version Model Number: OMZ-100 FACE MASK
• Company DUNS: 689458057
• Company Name: GTG Wellness 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: true
• 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	08809520341141 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2023-03-27
• Device Publish Date: 2023-03-17

On-Brand Devices [OMZ-100]

• 08809520341165: OMZ-100 NECK
• 08809520341141: OMZ-100 FACE MASK
• 08809520341134: OMZ-100 FULLSET