Vivera

GUDID 00816063020110

Retainer

ALIGN TECHNOLOGY, INC.

Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed Orthodontic teeth positioner, preformed

• Primary Device ID: 00816063020110
• NIH Device Record Key: 2308e3c9-8e55-43f6-9dba-d9ad79a0589c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivera
• Version Model Number: 8579
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063020110 [Primary]

FDA Product Code

• DYT: Maintainer, Space Preformed, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Vivera]

• 00816063020110: Retainer
• 00816063020028: Retainer