| Primary Device ID | 00190707000684 |
| NIH Device Record Key | 3a289554-f0b0-4ea0-bbb6-b9e80f5f3f23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ortho-Ease |
| Version Model Number | 470-160 |
| Company DUNS | 062165188 |
| Company Name | ORTHO ORGANIZERS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00190707000684 [Primary] |
| KLE | AGENT, TOOTH BONDING, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 00190707143107 - Band Assemblies | 2025-07-23 Elite.022/.045 UR6 Conv TplBT Tempra/Sheath 32.5 |
| 00190707143114 - Band Assemblies | 2025-07-23 Elite.022/.045 UL6 Conv TplBT Tempra/Sheath 32.5 |
| 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 |