| Primary Device ID | 00812282020610 |
| NIH Device Record Key | bb465ffa-310e-40e2-b002-fd04178dccb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Esteem Intraoperative System Analyzer |
| Version Model Number | 3200 |
| Catalog Number | 903200-002 |
| Company DUNS | 939725313 |
| Company Name | Envoy Medical Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812282020610 [Primary] |
| OAF | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-28 |
| 00812282020009 - Esteem® Sensor | 2018-12-21 Sensor Model 7010, IS-1 Connector |
| 00812282020016 - Esteem® Driver | 2018-12-21 Driver Model 7504, IS-1 Connector |
| 00812282020023 - Esteem® Driver | 2018-12-21 Driver Model 7504, IS-1 Connector |
| 00812282020030 - Esteem® Driver | 2018-12-21 Driver Model 7510, IS-1 Connector |
| 00812282020047 - Esteem® Sensor | 2018-12-21 Sensor Model 7004, IS-1 Connector |
| 00812282020054 - Esteem® Sensor | 2018-12-21 Sensor Model 7004, IS-1 Connector |
| 00812282020207 - Esteem® Sound Processor | 2018-12-21 Sound Processor Model 2001, IS-1 Connector Ports |
| 00812282020214 - Esteem® Sound Processor | 2018-12-21 Sound Processor Model 2001, IS-1 Connector Ports |