Invisalign Go

GUDID 00816063020127

Aligner

ALIGN TECHNOLOGY, INC.

Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner

• Primary Device ID: 00816063020127
• NIH Device Record Key: 59ce8754-b19b-4573-bc7d-b6299638638b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign Go
• Version Model Number: 8612
• Company DUNS: 013831768
• Company Name: ALIGN TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	00816063020127 [Primary]

FDA Product Code

• NXC: Aligner, Sequential

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 [Invisalign Go]

• 00816063020424: Sequential Aligner
• 00816063020127: Aligner