| Primary Device ID | 00816063020424 |
| NIH Device Record Key | 1550e04f-e379-4d31-8b89-4b6bbe0b40c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invisalign Go |
| Version Model Number | 9014 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816063020424 [Primary] |
| NXC | Aligner, Sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-16 |
| Device Publish Date | 2018-06-15 |
| 00816063020424 | Sequential Aligner |
| 00816063020127 | Aligner |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INVISALIGN GO 86850906 5845798 Live/Registered |
Align Technology, Inc. 2015-12-16 |