| Primary Device ID | 00861259000209 |
| NIH Device Record Key | d626e24a-c094-4e1b-b4e5-4143884172ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Serenade Tinnitus Treatment System |
| Version Model Number | 900000 |
| Company DUNS | 052252810 |
| Company Name | SOUNDCURE, INC. |
| 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 |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com | |
| Phone | 408-938-5745 |
| customerservice@soundcure.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861259000209 [Primary] |
| KLW | Masker, Tinnitus |
| 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 | 2016-09-01 |