| Primary Device ID | 00816063021384 |
| NIH Device Record Key | c50a131c-72d0-4406-a6a1-45497b50aba9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invisalign Palatal Holder |
| Version Model Number | 9032 |
| 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00816063021384 [Primary] |
| NXC | Aligner, Sequential |
| PNN | Orthodontic Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-11 |
| Device Publish Date | 2024-01-03 |
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