| Primary Device ID | 00627908020185 |
| NIH Device Record Key | 6129ef25-6b7c-4e18-9051-f3ccf2a5a2eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ECochG Adapters |
| Version Model Number | E-110 |
| 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 | 00627908020185 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
| 00627908020192 - Bone Conductor | 2023-06-20 |
| 00627908020178 - EP Headphones | 2023-06-16 |
| 00627908020185 - ECochG Adapters | 2023-06-16 |
| 00627908020185 - ECochG Adapters | 2023-06-16 |
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| 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 |