| Primary Device ID | 18257200080717 |
| NIH Device Record Key | 1cff1840-30e7-4695-b511-83faab9a0e84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthofix Osteogenesis Stimulator |
| Version Model Number | 3313 |
| Catalog Number | 653313-0017 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX 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 | false |
| Serial Number | true |
| 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200080717 [Primary] |
| LOF | Stimulator, bone growth, non-invasive |
| 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 | 2015-05-12 |
| 18257200080823 | Cervical-Stim Osteogenesis Stimulator, Demo |
| 18257200080816 | Cervical-Stim Osteogenesis Stimulator |
| 18257200080809 | Spinal-Stim Osteogensis Stimulator, Demo |
| 18257200080793 | Spinal-Stim Osteogenesis Stimulator |
| 18257200080786 | Physio-Stim Osteogenesis Stimulator, Demo |
| 18257200080779 | Physio-Stim Osteogenesis Stimulator |
| 18257200080762 | Physio-Stim Osteogensis Stimulator, Demo |
| 18257200080755 | Physio-Stim Osteogenesis Stimulator |
| 18257200080748 | Physio-Stim Osteogenesis Stimulator, Demo |
| 18257200080731 | Physio-Stim Osteogenesis Stimulator |
| 18257200080724 | Physio-Stim Osteogensis Stimulator, Demo |
| 18257200080717 | Physio-Stim Osteogenesis Stimulator |
| 18257200080700 | Physio-Stim Osteogenesis Stimulator, Demo |
| 18257200080694 | Physio-Stim Osteogenesis Stimulator |
| 18257200080687 | Physio-Stim Osteogenesis Stimulator, Demo |
| 18257200080670 | Physio-Stim Osteogenesis Stimulator |