| Primary Device ID | 00190707102388 |
| NIH Device Record Key | 8befeffc-c423-43fe-80c1-0d47607675e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bracketizer Instrument |
| Version Model Number | 200-329 |
| 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 | 00190707102388 [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 |
| 00190707128975 - Band Assemblies | 2025-07-15 .022 Elite LR6 Conv DBT -25T/0A/+4Off Tempra - Cleat 44 |
| 00190707128982 - Band Assemblies | 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 33 |
| 00190707128999 - Band Assemblies | 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 33.5 |
| 00190707129002 - Band Assemblies | 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 34 |
| 00190707129019 - Band Assemblies | 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 34.5 |
| 00190707129026 - Band Assemblies | 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 35 |
| 00190707129033 - Band Assemblies | 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 35.5 |
| 00190707129040 - Band Assemblies | 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 36 |