| 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 |
| 09008737335632 - Insertion Probe | 2024-11-01 Single-Use Surgical Tool |
| 09008737369736 - ANTS Connector Cable | 2024-11-01 Cable |
| 09008737370053 - Stimulator Box | 2024-11-01 Hardware Interface System |
| 09008737371371 - ANTS Electrode | 2024-11-01 Diagnostic Electrode |
| 09008737405557 - Insertion Probe L | 2024-11-01 Single-Use Surgical Tool |
| 09008737415433 - Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet | 2024-10-23 Cochlear Implant |
| 09008737415440 - Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet | 2024-10-23 Cochlear Implant |
| 09008737416218 - Insertion Electrode FLEX34 | 2024-10-23 Insertion Electrode |