TEETH WHITENING KIT

GUDID 00681131430333

LED WHITENING ACCELERATOR LIGHT + WHITENING PENS

Gurunanda, LLC

Tooth-bleaching acceleration unit

• Primary Device ID: 00681131430333
• NIH Device Record Key: 5a375828-fee3-4e57-a6a8-3b056168331e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEETH WHITENING KIT
• Version Model Number: IVUL-06W-V1
• Company DUNS: 079671169
• Company Name: Gurunanda, LLC
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681131430333 [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: 2023-05-05
• Device Publish Date: 2023-04-27

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