| Primary Device ID | 09008737421724 |
| NIH Device Record Key | b6a79178-eeae-4f54-8458-f33cf1694a28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAESTRO System Software 10 |
| Version Model Number | 42172 |
| Company DUNS | 300764032 |
| Company Name | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
| 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 | 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 | true |
| 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 | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008737421724 [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 | 2024-07-08 |
| Device Publish Date | 2024-06-30 |
| 09008737049997 - OPUS 2 FM Extension Kit anthracite | 2026-03-19 Audio Processor Battery Kit |
| 09008737050009 - OPUS 2 Children's Extension Kit anthracite | 2026-03-19 Audio Processor Battery Kit |
| 09008737050030 - OPUS 2 FM Extension Kit beige | 2026-03-19 Audio Processor Battery Kit |
| 09008737050047 - OPUS 2 Children's Extension Kit beige | 2026-03-19 Audio Processor Battery Kit |
| 09008737050078 - OPUS 2 FM Extension Kit red | 2026-03-19 Audio Processor Battery Kit |
| 09008737050085 - OPUS 2 Children's Extension Kit red | 2026-03-19 Audio Processor Battery Kit |
| 09008737050115 - OPUS 2 FM Extension Kit blue | 2026-03-19 Audio Processor Battery Kit |
| 09008737050122 - OPUS 2 Children's Extension Kit blue | 2026-03-19 Audio Processor Battery Kit |