| Primary Device ID | 04548213020447 |
| NIH Device Record Key | b2b448c7-ea70-4fee-a583-5a35cd174b0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Veraviewepocs 3D R100 |
| Version Model Number | X-550 |
| 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 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548213020447 [Primary] |
| MUH | System,X-Ray,Extraoral Source,Digital |
| 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 | 2016-08-27 |
| 04548213020447 | X-550 |
| 04548213020423 | X-550 |