| Primary Device ID | 00190707006778 |
| NIH Device Record Key | 31280ab2-03b8-49ec-ab29-6c14417c19fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoCrystal Plus |
| Version Model Number | 715-351HK-5 |
| 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 | true |
| 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 | 00190707006778 [Primary] |
| NJM | Bracket, ceramic, orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00190707007126 | NeoCrystal Plus .022 Kit U/L 5x5 Roth HKS |
| 00190707007119 | NeoCrystal Plus .022 Kit U/L 5x5 MC (0T) HKS |
| 00190707007102 | NeoCrystal Plus .022 Kit U/L 5x5 Roth HK |
| 00190707007096 | NeoCrystal Plus .022 Kit U/L 5x5 MC (0T) HK |
| 00190707007089 | NeoCrystal Plus .022 LL5 HK -21T 0A |
| 00190707007072 | NeoCrystal Plus .022 LL5 -21T 0A |
| 00190707007065 | NeoCrystal Plus .022 LR5 HK -21T 0A |
| 00190707007058 | NeoCrystal Plus .022 LR5 -21T 0A |
| 00190707007041 | NeoCrystal Plus .022 LL5 -17T 2A |
| 00190707007034 | NeoCrystal Plus .022 LL5 -17T 2A |
| 00190707007027 | NeoCrystal Plus .022 LR5 HK -17T 2A |
| 00190707007010 | NeoCrystal Plus .022 LR5 -17T 2A |
| 00190707007003 | NeoCrystal Plus .022 LL4 HK -17T 0A |
| 00190707006990 | NeoCrystal Plus .022 LL4 -17T 0A |
| 00190707006983 | NeoCrystal Plus .022 LR4 HK -17T 0A |
| 00190707006976 | NeoCrystal Plus .022 LR4 -17T 0A |
| 00190707006969 | NeoCrystal Plus .022 LL4 HK -12T 2A |
| 00190707006952 | NeoCrystal Plus .022 LL4 -12T 2A |
| 00190707006945 | NeoCrystal Plus .022 LR4 -12T 2A |
| 00190707006938 | NeoCrystal Plus .022 LR4 -12T 2A |
| 00190707006921 | NeoCrystal Plus .022 LL3 HK 0T 3A |
| 00190707006914 | NeoCrystal Plus .022 LR3 HK 0T 3A |
| 00190707006907 | NeoCrystal Plus .022 LL3 HK -11T 7A |
| 00190707006891 | NeoCrystal Plus .022 LR3 HK -11T 7A |
| 00190707006884 | NeoCrystal Plus .022 UL 4/5 HK -7T 0A |
| 00190707006877 | NeoCrystal Plus .022 UL 4/5 -7T 0A |
| 00190707006860 | NeoCrystal Plus .022 UR 4/5 HK -7T 0A |
| 00190707006853 | NeoCrystal Plus .022 UR 4/5 -7T 0A |
| 00190707006846 | NeoCrystal Plus .022 UL 4/5 HK -7T 0A |
| 00190707006839 | NeoCrystal Plus .022 UL 4/5 -7T 0A |
| 00190707006822 | NeoCrystal Plus .022 UR 4/5HK -7T 0A |
| 00190707006815 | NeoCrystal Plus .022 UR 4/5 -7T 0A |
| 00190707006808 | NeoCrystal Plus .022 UL3 HK - 0T 8A |
| 00190707006792 | NeoCrystal Plus .022 UR3 HK - 0T 8A |
| 00190707006785 | NeoCrystal Plus .022 UL3 HK -2T 8A |
| 00190707006778 | NeoCrystal Plus .022 UR3 HK -2T 8A |
| 00190707006761 | NeoCrystal Plus .022 LL/R 1/2 -6T 0A |
| 00190707006754 | NeoCrystal Plus .022 LL/R 1/2 0T 0A |
| 00190707006747 | NeoCrystal Plus .022 UL2 10T 8A |
| 00190707006730 | NeoCrystal Plus .022 UR2 10T 8A |
| 00190707006723 | NeoCrystal Plus .022 UL2 8T 9A |
| 00190707006716 | NeoCrystal Plus .022 UR2 8T 9A |
| 00190707006709 | NeoCrystal Plus .022 UL1 17T 4A |
| 00190707006693 | NeoCrystal Plus .022 UR1 17T 4A |
| 00190707006686 | NeoCrystal Plus .022 UL1 11T 5A |
| 00190707006679 | NeoCrystal Plus .022 UR1 11T 5A |
| 00190707006662 | NeoCrystal Plus .018 Kit U/L 5x5 Roth HKS |
| 00190707006655 | NeoCrystal Plus .018 Kit U/L 5x5 MC (0T) HKS |
| 00190707006648 | NeoCrystal Plus .018 Kit U/L 5x5 Roth HK |
| 00190707006631 | NeoCrystal Plus .018 Kit U/L 5x5 MC (0T) HK |