| Primary Device ID | 08500042230004 |
| NIH Device Record Key | 02027ac9-a5b6-47d6-8740-654313b756a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Candid Aligner |
| Version Model Number | FA-0001 |
| Company DUNS | 108729170 |
| Company Name | CANDID CARE CO. |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08500042230004 [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 | 2020-10-12 |
| Device Publish Date | 2020-10-02 |
| 00850004223222 | Candid Aligner System FA-0003 |
| 08500042230004 | Candid Aligner System FA-0001 |
| 00850004223567 | Candid Aligner System FA-0001 |