| Primary Device ID | 86941673501497 |
| NIH Device Record Key | e8bbed4d-95a1-4584-bf0d-d75ca35a7041 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial |
| Version Model Number | 1212-014Hm |
| Company DUNS | 547794613 |
| Company Name | Astar Orthodontics Inc. |
| Device Count | 50 |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 06941673501491 [Primary] |
| GS1 | 86941673501497 [Unit of Use] |
| EJF | Bracket, Metal, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-08 |
| Device Publish Date | 2023-12-31 |
| 86941673501459 - Thino Roth Bracket, .022, Mini Size, UL1 | 2024-01-08 |
| 86941673501466 - Thino Roth Bracket, .022, Mini Size, UL2 | 2024-01-08 |
| 86941673501473 - Thino Roth Bracket, .022 Mini, UL3, w/hk at distal | 2024-01-08 |
| 86941673501480 - Thino Roth Bracket, .022 Mini, UL4, w/o hook | 2024-01-08 |
| 86941673501497 - Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial | 2024-01-08 |
| 86941673501497 - Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial | 2024-01-08 |
| 86941673501503 - Thino Roth Bracket, .022 Mini, UL4, w/hk at distal | 2024-01-08 |
| 86941673501510 - Thino Roth Bracket, .022 Mini, UL5, w/o hook | 2024-01-08 |
| 86941673501527 - Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial | 2024-01-08 |