| Primary Device ID | 08033837932901 |
| NIH Device Record Key | e493407b-6358-4974-80c1-386e3a03a4e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NewTom |
| Version Model Number | NewTom GO (3D CEPH) |
| Catalog Number | 70BE0000 |
| Company DUNS | 429341410 |
| Company Name | CEFLA SOCIETA' COOPERATIVA |
| 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 | 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 |
| Phone | +1 (704)598-0020 |
| service@cefladental.com | |
| Phone | +1 (704)598-0020 |
| service@cefladental.com |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 71 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033837932901 [Primary] |
| MUH | System,X-Ray,Extraoral Source,Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-12 |
| Device Publish Date | 2020-05-04 |