| 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) |