| Primary Device ID | 00190707102845 |
| NIH Device Record Key | a338d19b-038d-48cd-8684-4b31ad604f77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Buccal Tube Bonder Tweezer |
| Version Model Number | 200-324 |
| Company DUNS | 062165188 |
| Company Name | ORTHO ORGANIZERS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00190707102845 [Primary] |
| ECQ | ALIGNER, BRACKET, 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 | 2022-10-25 |
| Device Publish Date | 2022-10-17 |
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| 10190707086494 - Triumph® | 2026-01-15 Triumph® Safety Hold Replacement Silicone Insert |
| 00190707086503 - Triumph® | 2026-01-15 Triumph® Adhesive Remover - Replacement Blade |
| 10190707086517 - Triumph® | 2026-01-15 Triumph® Adhesive Remover - 1/4" Replacement Pads |
| 10190707086524 - Triumph® | 2026-01-15 Triumph® Band Remover - 3/16" Replacement Pads |
| 10190707086531 - Triumph® | 2026-01-15 Triumph® Band Remover - 1/4" Replacement Pads |
| 00190707102975 - Carriere® Motion Pro™ | 2026-01-13 Carriere® Motion Pro™ Clear Bite Corrector 18 mm 1-Set |
| 00190707103002 - Carriere® Motion Pro™ | 2026-01-13 Carriere® Motion Pro™ Clear Bite Corrector 20 mm 1-Set |