| Primary Device ID | 05713315008856 |
| NIH Device Record Key | 3dc4aad6-c85a-418c-a6c0-1e16974008c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 1077 AccuScreen |
| Version Model Number | 8-04-13904 |
| Company DUNS | 306633756 |
| Company Name | Gn Otometrics A/S |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05713315008856 [Primary] |
| GWJ | Stimulator, Auditory, Evoked Response |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-04 |
| Device Publish Date | 2021-04-26 |
| 05713315008726 - Disposable Snap Electrodes (3 pack) | 2023-12-18 |
| 05713315008733 - Disposable Snap Electrodes (25 x 3 pack) | 2023-12-18 |
| 05713315010279 - Madsen A450 | 2023-08-03 1081 Madsen A450 |
| 05713315010286 - Madsen A450 | 2023-08-03 1081 Madsen A450 |
| 05713315010293 - Madsen A450 | 2023-08-03 1081 Madsen A450 |
| 05713315009464 - Madsen Zodiac | 2023-07-12 1096 Zodiac PC QC |
| 05713315010699 - Otoscan | 2023-05-19 1093,OTOSCAN Bundle – Scanner & Headset without laptop |
| 05713315009969 - Bone Conductor (BC-2) | 2023-03-17 BC-2 Bone Conductor With Headband |