| Primary Device ID | 00627908020192 |
| NIH Device Record Key | 3805132f-e00f-4baf-8c89-91b0589f33c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Conductor |
| Version Model Number | B81 |
| Company DUNS | 201740425 |
| Company Name | Vivosonic 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627908020192 [Primary] |
| GWJ | Stimulator, Auditory, Evoked Response |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-20 |
| Device Publish Date | 2023-06-12 |
| 00627908020192 - Bone Conductor | 2023-06-20 |
| 00627908020192 - Bone Conductor | 2023-06-20 |
| 00627908020178 - EP Headphones | 2023-06-16 |
| 00627908020185 - ECochG Adapters | 2023-06-16 |
| 00627908020154 - Integrity VivoStim | 2020-05-12 Sound stimulator for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017). The UDI is compr |
| 00627908010018 - Integrity V500 | 2020-04-21 Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is comprised of the following: GTI |
| 00627908010025 - Integrity Amplitrode | 2020-04-21 One channel Amplitrode for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI i |
| 00627908010032 - Integrity Bone Conductor | 2020-04-21 Bone conductor for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is compris |
| 00627908010049 - Integrity Insert Earphones | 2020-04-21 ER-3A insert earphones for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI i |