Gemini

GUDID 00857848007094

Beyond International Inc.

Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit

• Primary Device ID: 00857848007094
• NIH Device Record Key: 3d90a627-ad11-45ed-ad50-f924519ea83c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gemini
• Version Model Number: BY-GM224
• Company DUNS: 080721790
• Company Name: Beyond International Inc.
• 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: true
• 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	00857848007094 [Primary]

FDA Product Code

• EEG: Heat Source For Bleaching Teeth

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: 2023-05-16
• Device Publish Date: 2023-05-08