| Primary Device ID | 00850016231222 |
| NIH Device Record Key | 528f76e4-3989-496a-bf64-e375838a9927 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Soundwave Hearing |
| Version Model Number | 991004-SWH |
| Company DUNS | 050441605 |
| Company Name | Soundwave Hearing, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850016231222 [Primary] |
| OSM | Hearing Aid, Air Conduction With Wireless Technology |
| QUG | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-09 |
| Device Publish Date | 2021-11-01 |
| 00850016231352 | 991019-SWH; retention lock for RIC |
| 00850016231345 | POWER-LARGE/991016-SWH; 10-pc blister pack of replacement ear domes for RIC |
| 00850016231338 | POWER-MEDIUM/991015-SWH; 10-pc blister pack of replacement ear domes for RIC |
| 00850016231321 | POWER-SMALL/991014-SWH; 10-pc blister pack of replacement ear domes for RIC |
| 00850016231314 | TULIP-ONE SIZE (12MM)/991013-SWH; 10-pc blister pack of replacement ear domes for RIC |
| 00850016231307 | OPEN-LARGE/991012-SWH; 10-pc blister pack of replacement ear domes for RIC |
| 00850016231291 | OPEN-MEDIUM/991011-SWH; 10-pc blister pack of replacement ear domes for RIC |
| 00850016231284 | OPEN-SMALL/991010-SWH; 10-pc blister pack of replacement ear domes for RIC |
| 00850016231277 | LEFT-LARGE/991009-SWH; replacement RIC for Sontro™ Hearing Aids |
| 00850016231260 | LEFT-MEDIUM/991008-SWH; replacement RIC for Sontro™ Hearing Aids |
| 00850016231253 | LEFT-SMALL/991007-SWH; replacement RIC for Sontro™ Hearing Aids |
| 00850016231246 | RIGHT-LARGE/991006-SWH; replacement RIC for Sontro™ Hearing Aids |
| 00850016231239 | RIGHT-MEDIUM/991005-SWH; replacement RIC for Sontro™ Hearing Aids |
| 00850016231222 | RIGHT-SMALL/991004-SWH; replacement RIC for Sontro™ Hearing Aids |