| Primary Device ID | 05906874392010 |
| NIH Device Record Key | 6608604e-774c-49ac-8c9a-4fa7d55887ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SACCADOMETER |
| Version Model Number | PLUS |
| Company DUNS | 522393420 |
| Company Name | OBER CONSULTING SP Z O O |
| 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 | +48505940787 |
| info@ober-consulting.com |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05906874392010 [Primary] |
| HLL | Monitor, Eye Movement |
| 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 | 2017-01-26 |
| 05906874392027 | The Saccadometer Adavnced system measures eye movements in horizontal axis with temporal 1kHz an |
| 05906874392010 | The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and sp |