| Primary Device ID | 04548213013227 |
| NIH Device Record Key | aa11ced2-0cfc-4748-9199-bbb112ae5d0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Root ZX II Canal Measurement Module |
| Version Model Number | DP-ZX |
| Company DUNS | 693811465 |
| Company Name | J.MORITA MFG.CORP. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 70 Degrees Celsius |
| Storage Environment Humidity | Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |