Invisalign UV Sanitizing Case

GUDID 00816063021896

The Invisalign UV Sanitizing Case is a portable, over-the-counter device that is intended to sanitize Invisalign clear aligners.

Align Technology, Inc.

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• Primary Device ID: 00816063021896
• NIH Device Record Key: d6c2b032-19fc-4a49-9233-9edfcd33fa74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign UV Sanitizing Case
• Version Model Number: 214150
• Company DUNS: 013831768
• Company Name: Align Technology, 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063021896 [Primary]

FDA Product Code

• NOB: Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile

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: 2023-08-01
• Device Publish Date: 2023-07-24

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