| Primary Device ID | 09008738500558 |
| NIH Device Record Key | 7c3e6065-690f-493d-b56b-2e5618515961 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | VORP Sizer Kit |
| 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 | 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Shall be stored at room temperature protected from moisture and direct heat. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008738500558 [Primary] |
| MPV | Implant, Hearing, Active, Middle Ear, Partially Implanted |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-03 |
| Device Publish Date | 2014-09-22 |
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| 09008737383022 - SONNET 3 BabyWear Kit (DL) Beige | 2025-03-07 Audio Processor Accessory |
| 09008737383039 - SONNET 3 BabyWear Kit (DL) Nordic Gray | 2025-03-07 Audio Processor Accessory |
| 09008737385842 - SONNET 3 BabyWear Kit (DL) Black | 2025-03-07 Audio Processor Accessory |
| 09008737412180 - FineTuner Echo | 2025-03-06 Audio Processor Remote Control |
| 09008737413415 - AudioKey 3 | 2025-03-06 Mobile application (iOS) |
| 09008737413422 - AudioKey 3 | 2025-03-06 Mobile application (Android) |
| 09008737434830 - SONNET 3 Kit (Me1710) BAT FTE Anthracite | 2025-03-06 Audio Processor Kit |