Sontro™ Hearing Aids
GUDID 00850016231116
BEIGE/99/0011-SWH; set of Sontro™ Hearing Aids (Model: AI)
Soundwave Hearing, LLC
Air-conduction hearing aid, receiver-in-canal| Primary Device ID | 00850016231116 |
| NIH Device Record Key | 654adf39-f9db-4a69-9d0d-ce3800640501 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sontro™ Hearing Aids |
| Version Model Number | 990011-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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850016231116 [Primary] |
FDA Product Code
| 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 |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-09 |
| Device Publish Date | 2021-11-01 |
On-Brand Devices [Sontro™ Hearing Aids]
| 00850016231178 | BEIGE/990017-SWH; left (refurbished) replacement for Sontro™ Hearing Aids (Model: AI) |
| 00850016231161 | BEIGE/990016-SWH; right (refurbished) replacement for Sontro™ Hearing Aids (Model: AI) |
| 00850016231147 | BEIGE/990014-SWH; left replacement for Sontro™ Hearing Aids (Model: AI) |
| 00850016231130 | BEIGE/990013-SWH; right replacement for Sontro™ Hearing Aids (Model: AI) |
| 00850016231116 | BEIGE/99/0011-SWH; set of Sontro™ Hearing Aids (Model: AI) |
| 00850016231086 | GREY/990008-SWH; left (refurbished) replacement for Sontro™ Hearing Aids (Model: AI) |
| 00850016231079 | GREY/990007-SWH; right (refurbished) replacement for Sontro™ Hearing Aids (Model: AI) |
| 00850016231055 | GREY/990005-SWH; left replacement for Sontro™ Hearing Aids (Model: AI) |
| 00850016231048 | GREY/990004-SWH; right replacement for Sontro™ Hearing Aids (Model: AI) |
| 00850016231024 | GREY/990002-SWH; set of Sontro™ Hearing Aids (Model: AI) |
Trademark Results [Sontro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONTRO 88983626 not registered Live/Pending |
Soundwave Hearing, LLC 2019-05-02 |
 SONTRO 88412497 not registered Live/Pending |
Soundwave Hearing, LLC 2019-05-02 |
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