| 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 |
| 00190707183479 - Accufit | 2024-04-12 AccuFit Molar Band UR6 - 37 |
| 00190707183486 - Accufit | 2024-04-12 AccuFit Molar Band UL7 - 36.5 |
| 00190707183493 - Accufit | 2024-04-12 Accufit Molar Bands Lower Left First Molar 29 1/2 |
| 00190707183509 - Accufit | 2024-04-12 Accufit Molar Bands Lower Left First Molar 30 |
| 00190707183516 - Accufit | 2024-04-12 Accufit Molar Bands Lower Left First Molar 30 1/2 |
| 00190707183523 - Accufit | 2024-04-12 Accufit Molar Bands Lower Left First Molar 31 |
| 00190707183530 - Accufit | 2024-04-12 Accufit Molar Bands Lower Left First Molar 31 1/2 |
| 00190707183547 - Accufit | 2024-04-12 Accufit Molar Bands Lower Left First Molar 32 |