OPUS 2 04313
GUDID 09008737043131
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Cochlear implant system| Primary Device ID | 09008737043131 |
| NIH Device Record Key | 0eb96255-a5e8-450d-b0dc-2260decfb3f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPUS 2 |
| Version Model Number | OPUS 2 Battery Pack anthracite |
| Catalog Number | 04313 |
| 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 | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008737043131 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P000025
FDA Product Code
| MCM | Implant, Cochlear |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-10-19 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [OPUS 2]
| 09008737363871 | OPUS 2 Control Unit blue, Service Pool (SP) |
| 09008737363864 | OPUS 2 Control Unit ebony, Service Pool (SP) |
| 09008737363857 | OPUS 2 Control Unit white, Service Pool (SP) |
| 09008737363840 | OPUS 2 Control Unit grey, Service Pool (SP) |
| 09008737363833 | OPUS 2 Control Unit beige, Service Pool (SP) |
| 09008737363826 | OPUS 2 Control Unit anthracite, Service Pool (SP) |
| 09008737092672 | OPUS 2XS UpgrKit baby pink |
| 09008737092665 | OPUS 2XS UpgrKit baby blue |
| 09008737092658 | OPUS 2XS UpgrKit green |
| 09008737092641 | OPUS 2XS UpgrKit orange |
| 09008737092634 | OPUS 2XS UpgrKit creme |
| 09008737092627 | OPUS 2XS UpgrKit ebony |
| 09008737092610 | OPUS 2XS UpgrKit white |
| 09008737092603 | OPUS 2XS UpgrKit brown |
| 09008737092597 | OPUS 2XS UpgrKit red |
| 09008737092580 | OPUS 2XS UpgrKit blue |
| 09008737092573 | OPUS 2XS UpgrKit grey |
| 09008737092566 | OPUS 2XS UpgrKit beige |
| 09008737092559 | OPUS 2XS UpgrKit anthracite |
| 09008737092542 | OPUS 2XS ExtKit baby pink |
| 09008737092535 | OPUS 2XS ExtKit baby blue |
| 09008737092528 | OPUS 2XS ExtKit green |
| 09008737092511 | OPUS 2XS ExtKit orange |
| 09008737092504 | OPUS 2XS ExtKit creme |
| 09008737092498 | OPUS 2XS ExtKit ebony |
| 09008737092481 | OPUS 2XS ExtKit white |
| 09008737092474 | OPUS 2XS ExtKit brown |
| 09008737092467 | OPUS 2XS ExtKit red |
| 09008737092450 | OPUS 2XS ExtKit blue |
| 09008737092443 | OPUS 2XS ExtKit grey |
| 09008737092436 | OPUS 2XS ExtKit beige |
| 09008737092429 | OPUS 2XS ExtKit anthracite |
| 09008737089542 | OPUS 2 BP ExtKit US babypink |
| 09008737089535 | OPUS 2 BP ExtKit US babyblue |
| 09008737089528 | OPUS 2 BP ExtKit US green |
| 09008737089511 | OPUS 2 BP ExtKit US orange |
| 09008737089504 | OPUS 2 BP ExtKit US creme |
| 09008737089498 | OPUS 2 BP ExtKit US ebony |
| 09008737089481 | OPUS 2 BP ExtKit US white |
| 09008737076115 | OPUS 2 D Coil Baby Kit b-pink |
| 09008737076108 | OPUS 2 D Coil Baby Kit b-blue |
| 09008737076092 | OPUS 2 D Coil Baby Kit green |
| 09008737076085 | OPUS 2 D Coil Baby Kit orange |
| 09008737076078 | OPUS 2 D Coil Baby Kit creme |
| 09008737076061 | OPUS 2 D Coil Baby Kit ebony |
| 09008737076054 | OPUS 2 D Coil Baby Kit white |
| 09008737076047 | OPUS 2 D Coil Baby Kit brown |
| 09008737076030 | OPUS 2 D Coil Baby Kit grey |
| 09008737076023 | OPUS 2 D Coil Baby Kit blue |
| 09008737076016 | OPUS 2 D Coil Baby Kit red |
Trademark Results [OPUS 2]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPUS 2 98001116 not registered Live/Pending |
Opus 2 Magnum Holdings Limited 2023-05-17 |
 OPUS 2 86596607 4962679 Live/Registered |
Opus 2 Magnum Holdings Limited 2015-04-14 |
 OPUS 2 77012921 3516933 Live/Registered |
Med-El Elektromedizinische Geräte Ges.m.b.H. 2006-10-03 |
 OPUS 2 75885240 not registered Dead/Abandoned |
OPUS 2 DIRECT.COM INC. 2000-01-07 |
 OPUS 2 73127266 1096663 Dead/Cancelled |
A. Schid A.G. 1977-05-19 |
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