| Primary Device ID | 10190707112995 |
| NIH Device Record Key | fb890e22-a8b4-454c-ab57-51846497f73d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pinnacle® |
| Version Model Number | 360-92-3412 |
| Company DUNS | 062165188 |
| Company Name | ORTHO ORGANIZERS, INC. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00190707112998 [Primary] |
| GS1 | 10190707112995 [Unit of Use] |
| EJF | BRACKET, METAL, 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 | 2025-10-06 |
| Device Publish Date | 2025-09-26 |
| 10190707113169 | Pinnacle .022 R LL/R 1/2 -1T 0A 0O (10PK) |
| 10190707113152 | Pinnacle .022 R LL5 HK G/O -22T 0A 4DO (10PK) |
| 10190707113145 | Pinnacle .022 R LL5 G/O -22T 0A 4DO (10PK) |
| 10190707113138 | Pinnacle .022 R LL5 HK -22T 0A 4DO (10PK) |
| 10190707113121 | Pinnacle .022 R LL5 -22T 0A 4DO (10PK) |
| 10190707113114 | Pinnacle .022 R LL4 HK G/O -17T 0A 4DO (10PK) |
| 10190707113107 | Pinnacle .022 R LL4 G/O -17T 0A 4DO (10PK) |
| 10190707113091 | Pinnacle .022 R LL4 HK -17T 0A 4DO (10PK) |
| 10190707113084 | Pinnacle .022 R LL4 -17T 0A 4DO (10PK) |
| 10190707113077 | Pinnacle .022 R LL3 HK -11T 7A 2MO (10PK) |
| 10190707113060 | Pinnacle .022 R LL3 -11T 7A 2MO (10PK) |
| 10190707113053 | Pinnacle .022 R LR5 HK G/O -22T 0A 4DO (10PK) |
| 10190707113046 | Pinnacle .022 R LR5 G/O -22T 0A 4DO (10PK) |
| 10190707113039 | Pinnacle .022 R LR5 HK -22T 0A 4DO (10PK) |
| 10190707113022 | Pinnacle .022 R LR5 -22T 0A 4DO (10PK) |
| 10190707113015 | Pinnacle .022 R LR4 HK G/O -17T 0A 4DO (10PK) |
| 10190707113008 | Pinnacle .022 R LR4 G/O -17T 0A 4DO (10PK) |
| 10190707112995 | Pinnacle .022 R LR4 HK -17T 0A 4DO (10PK) |
| 10190707112988 | Pinnacle .022 R LR4 -17T 0A 4DO (10PK) |
| 10190707112971 | Pinnacle .022 R LR3 HK -11T 7A 2MO (10PK) |
| 10190707112964 | Pinnacle .022 R LR3 -11T 7A 2MO (10PK) |
| 10190707112957 | Pinnacle .022 R UL 4/5 HK G/O -7T 0A 2DO (10PK) |
| 10190707112940 | Pinnacle .022 R UL 4/5 G/O -7T 0A 2DO (10PK) |
| 10190707112933 | Pinnacle .022 R UL 4/5 HK -7T 0A 2DO (10PK) |
| 10190707112926 | Pinnacle .022 R UL 4/5 -7T 0A 2DO (10PK) |
| 10190707112919 | Pinnacle .022 R UL3 HK -2T 13A 4MO (10PK) |
| 10190707112902 | Pinnacle .022 R UL3 -2T 13A 4MO (10PK) |
| 10190707112896 | Pinnacle .022 R UL2 +8T 9A 0O (10PK) |
| 10190707112889 | Pinnacle .022 R UL1 +12T 5A 0O (10PK) |
| 10190707112872 | Pinnacle .022 Roth U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK |
| 10190707112865 | Pinnacle .022 Roth U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK |
| 10190707112858 | Pinnacle .022 Roth U/L 5x5, OS Pad U/L 4/5 SPK |
| 10190707112841 | Pinnacle .022 Roth U/L 5x5 Hks 345 SPK PINNACLE |
| 10190707112834 | Pinnacle .022 Roth U/L 5x5 Hks 3 SPK PINNACLE |
| 10190707112827 | Pinnacle .022 Roth U/L 5x5 SPK PINNACLE |
| 10190707112810 | Pinnacle .022 R UR 4/5 HK G/O -7T 0A 2DO (10PK) |
| 10190707112803 | Pinnacle .022 R UR 4/5 G/O -7T 0A 2DO (10PK) |
| 10190707112797 | Pinnacle .022 R UR 4/5 HK -7T 0A 2DO (10PK) |
| 10190707112780 | Pinnacle .022 R UR 4/5 -7T 0A 2DO (10PK) PINNACLE |
| 10190707112773 | Pinnacle .022 R UR3 HK -2T 13A 4MO (10PK) |
| 10190707112766 | Pinnacle .022 R UR3 -2T 13A 4MO (10PK) PINNACLE |
| 10190707112759 | Pinnacle .022 R UR2 +8T 9A 0O (10PK) PINNACLE |
| 10190707112742 | Pinnacle .022 R UR1 +12T 5A 0O (10PK) PINNACLE |
| 10190707112735 | Pinnacle .018 R LL/R 1/2 -1T 0A 0O (10PK) |
| 10190707112728 | Pinnacle .018 R LL5 HK G/O -22T 0A 4DO (10PK) |
| 10190707112711 | Pinnacle .018 R LL5 G/O -22T 0A 4DO (10PK) |
| 10190707112704 | Pinnacle .018 R LL5 HK -22T 0A 4DO (10PK) |
| 10190707112698 | Pinnacle .018 R LL5 -22T 0A 4DO (10PK) PINNACLE |
| 10190707112681 | Pinnacle .018 R LL4 HK G/O -17T 0A 4DO (10PK) |
| 10190707112674 | Pinnacle .018 R LL4 G/O -17T 0A 4DO (10PK) |