| Primary Device ID | 09008737370053 |
| NIH Device Record Key | 9478458e-a344-4743-8fb6-6a43eb340d0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stimulator Box |
| Version Model Number | 37005 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008737370053 [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 | 2024-11-01 |
| Device Publish Date | 2024-10-24 |
| 09008737335632 - Insertion Probe | 2024-11-01 Single-Use Surgical Tool |
| 09008737369736 - ANTS Connector Cable | 2024-11-01 Cable |
| 09008737370053 - Stimulator Box | 2024-11-01Hardware Interface System |
| 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 |