| Primary Device ID | 05713315009563 |
| NIH Device Record Key | 9c3d42cf-2068-4c88-bb07-33e270d6884b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Madsen Zodiac |
| Version Model Number | 8-04-16317 |
| Catalog Number | 8-04-16317 |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05713315009563 [Primary] |
| ETY | Tester, Auditory Impedance |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-13 |
| Device Publish Date | 2022-12-05 |
| 05713315009846 | 1096 Zodiac PC Clinical |
| 05713315009778 | 1096 Zodiac PC Diagnostic |
| 05713315009723 | 1096 Zodiac SA Clinical w/o printer |
| 05713315009648 | 1096 Zodiac SA Clinical w. printer |
| 05713315009563 | 1096 Zodiac SA Diag. w/o printer |
| 05713315009495 | 1096 Zodiac SA Diag. w. printer |
| 05713315009440 | 1096 Zodiac SA QC w/o printer |
| 05713315009419 | 1096 Zodiac SA QC w. printer |
| 00571331500946 | 1096 Zodiac PC QC |
| 05713315009464 | 1096 Zodiac PC QC |