| Primary Device ID | 05713315008726 |
| NIH Device Record Key | 07826aa3-17e4-4f01-aa62-0dccd02c6fc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Snap Electrodes (3 pack) |
| Version Model Number | 8-64-21000 |
| Catalog Number | 8-64-21000 |
| 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 | true |
| Lot Batch | true |
| 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 |
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| 05713315007439 - MADSEN Astera 2 | 2024-12-20 1066 MADSEN Astera 2 w/ACP, ISO Cal. HB-7, Insert phone, DD450, B71 BC, Wall Mount Kit |
| 05713315007477 - MADSEN Astera 2 | 2024-12-20 1066 MADSEN Astera 2 without ACP ANSI Cal.Incl. ME70 Headset, Insert Earphone, BC-1 BC |
| 05713315007521 - MADSEN Astera 2 | 2024-12-20 1066 MADSEN Astera 2 with ACP, ISO Calibration Incl. ME70 Headset and BC-1 Bone conductor |
| 05713315007859 - MADSEN Astera 2 | 2024-12-20 1066 MADSEN Astera 2 with ACPDS, Including HB-7 Headset, Insert Phone and DD450 |
| 05713315007132 - GN Otometrics A/S | 2024-12-12 |
| 05713315011054 - Otoscan | 2024-04-23 1093,OTOSCAN Yearly – Scanner & Headset without laptop, yearly Otocloud subscription |
| 05713315008726 - Disposable Snap Electrodes (3 pack) | 2023-12-18 |
| 05713315008726 - Disposable Snap Electrodes (3 pack) | 2023-12-18 |