| Primary Device ID | 07613389808513 |
| NIH Device Record Key | 8e58a94b-387a-4fde-b1fd-bd028c3ebc58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonite R Kit Binaural US |
| Version Model Number | (silver gray) |
| Catalog Number | 051-0231-P656 |
| Company DUNS | 480662550 |
| Company Name | Sonova AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | 07613389808513 [Primary] |
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-28 |
| Device Publish Date | 2025-03-20 |
| 07613389804164 | (beige) |
| 07613389808520 | Sonite R Kit Binaural US (velvet black) - Primary DI number: 07613389808520 2x Sennheiser Sonite |
| 07613389808513 | Sonite R Kit Binaural US (silver gray) - Primary DI number: 07613389808513 2x Sennheiser Sonite |
| 07613389808506 | Sonite R Kit Binaural US (sandalwood) - Primary DI number: 07613389808506 2x Sennheiser Sonite R |