| Primary Device ID | 00851067007057 |
| NIH Device Record Key | 6eecfaa4-2300-4d2d-ac7e-6e17e2bb909b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SuniIQ |
| Version Model Number | Sensor Size #2 |
| Catalog Number | 400-1322 |
| Company DUNS | 180451106 |
| Company Name | SUNI MEDICAL IMAGING, INC. |
| 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 | true |
| 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 |
| Phone | 1-408-227-6698 |
| support@suni.com |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851067007057 [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 | 2017-03-17 |
| 00851067007057 | The SuniIQ Digital Radiography System is a semiconductor imaging device intended to acquire real |
| 00851067007040 | The SuniIQ Digital Radiography System is a semiconductor imaging device intended to acquire real |