| Primary Device ID | 00816063021407 |
| NIH Device Record Key | 6c92cc84-e288-4b28-b5af-ef7388e7d08c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cleaning Crystals, Packette |
| Version Model Number | 20127 |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816063020301 [Package] Package: bulk 250 [250 Units] In Commercial Distribution |
| GS1 | 00816063020318 [Package] Package: 50ct kit [50 Units] In Commercial Distribution |
| GS1 | 00816063021162 [Package] Package: 3 pack [3 Units] In Commercial Distribution |
| GS1 | 00816063021179 [Package] Package: kit [50 Units] In Commercial Distribution |
| GS1 | 00816063021407 [Primary] |
| EFT | Cleanser, Denture, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-14 |
| Device Publish Date | 2022-12-06 |
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