| Primary Device ID | 05711781001715 |
| NIH Device Record Key | 7df7f736-ec2f-4494-bce4-a7679128cfdc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OTOSphere By Auditdata |
| Version Model Number | OTOSphere |
| Company DUNS | 310385849 |
| Company Name | Auditdata A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05711781001715 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-24 |
| 05711781004006 - Unity 3 | 2024-10-29 U3HIT Package AD-version US |
| 05711781002743 - Measure | 2024-09-25 2000-1 Fitting Unit Audiometer SW |
| 05711781003818 - Unity 4 / Measure | 2024-09-25 |
| 00571178100316 - Unity 4 | 2024-08-29 2000-1 Fitting Unit Audiometer |
| 05711781002729 - Unity 4 / Measure | 2024-08-29 2000-1 Fitting Unit Audiometer |
| 05711781002736 - Unity 4 / Measure | 2024-08-29 2000-1 Fitting Unit Audiometer |
| 05711781002750 - Unity 4 | 2024-08-29 2000-1 Fitting Unit Audiometer |
| 05711781002774 - Unity 4 / Measure | 2024-08-29 2000-1 Fitting Unit Audiometer |