| Primary Device ID | 09008737413415 |
| NIH Device Record Key | 824f68f0-8b08-4889-9f77-1b0eaeb79fde |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AudioKey 3 |
| Version Model Number | 41341 |
| Company DUNS | 300764032 |
| Company Name | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
| 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 | false |
| 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 |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008737413415 [Primary] |
| MCM | Implant, Cochlear |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-06 |
| Device Publish Date | 2025-02-26 |
| 09008737413422 | Mobile application (Android) |
| 09008737413415 | Mobile application (iOS) |