Vivera

GUDID 00816063020028

Retainer

ALIGN TECHNOLOGY, INC.

Orthodontic teeth positioner, preformed

• Primary Device ID: 00816063020028
• NIH Device Record Key: 16ab39d4-ae4a-4485-990d-6ffaa5cd66fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivera
• Version Model Number: 7883
• 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	00816063020028 [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