| Primary Device ID | 03663227803068 |
| NIH Device Record Key | 7d0373d3-c04d-43c8-aa8a-6f36dcc2827c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neuro Cochlear Implant System |
| Version Model Number | M80306 |
| Company DUNS | 285420530 |
| Company Name | NEURELEC |
| 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 | true |
| 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 | 03663227803068 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
[03663227803068]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-06 |
| Device Publish Date | 2021-08-27 |
| 03663227803884 | Neuro Zti screwdriver blade |
| 03663227803877 | Neuro Zti screwdriver handle |
| 03663227803068 | Insertion Fork |
| 03663227801798 | Neuro Zti Dummy Magnet |
| 03663227801774 | Neuro Zti Magnet Extractor |
| 03663227801750 | Insertion forceps |
| 03663227801743 | Neuro Zti Fixation Screws |
| 03663227801736 | Neuro Zti screwdriver |
| 03663227004014 | Programming Device, Left Wired |
| 03663227004007 | Programming Device, Right Wired |
| 03663227003956 | TAMPER, NEURO2 TOOL |
| 03663227003864 | PACKING SET, CHARGEUR |
| 03663227002355 | PACKING SET, THIN SAFETY LINE |
| 03663227002140 | CLIP, NEURO2 |
| 03663227002126 | EAR PLUG, RETENTION KIT NEURO2 |
| 03663227801811 | Probe Array |
| 03663227801804 | Neuro Zti implant indicator |
| 03663227801781 | Neuro Zti Magnet |
| 03663227003949 | SAFETY LINE, CI |
| 03663227003840 | CARE KIT, NEURO2 |
| 03663227002003 | Neuro processor indicator |
| 03663227801859 | Neuro Zti EVO |
| 03663227801842 | Neuro ZtiCLA |
| 03663227002430 | SOUND PROCESSOR, NEURO2 ZTI C098 |
| 03663227002423 | SOUND PROCESSOR, NEURO2 ZTI C094 |
| 03663227002416 | SOUND PROCESSOR, NEURO2 ZTI C093 |
| 03663227002409 | SOUND PROCESSOR, NEURO2 ZTI C092 |
| 03663227002393 | SOUND PROCESSOR, NEURO2 ZTI C091 |
| 03663227002379 | SOUND PROCESSOR, NEURO2 ZTI C057 |
| 03663227002362 | SOUND PROCESSOR, NEURO2 ZTI C044 |
| 03663227001976 | CI-LINK OPERATING ROOM KIT (ZTI) |
| 03663227001969 | CI-LINK FITTING ROOM KIT |
| 03663227001631 | SET, SOUND PROCESSOR NEURO2 ZTI C098 |
| 03663227001624 | SET, SOUND PROCESSOR NEURO2 ZTI C094 |
| 03663227001617 | SET, SOUND PROCESSOR NEURO2 ZTI C093 |
| 03663227001600 | SET, SOUND PROCESSOR NEURO2 ZTI C092 |
| 03663227001594 | SET, SOUND PROCESSOR NEURO2 ZTI C091 |
| 03663227001587 | SET, SOUND PROCESSOR NEURO2 ZTI C090 |
| 03663227001570 | SET, SOUND PROCESSOR NEURO2 ZTI C063 |
| 03663227001563 | SET, SOUND PROCESSOR NEURO2 ZTI C058 |
| 03663227001556 | SET, SOUND PROCESSOR NEURO2 ZTI C057 |
| 03663227001549 | SET, SOUND PROCESSOR NEURO2 ZTI C044 |
| 03663227001532 | Genie Medical CI Fitting Software |
| 03663227001471 | SOUND PROCESSOR, NEURO2 ZTI C063 |
| 03663227001464 | SOUND PROCESSOR, NEURO2 ZTI C090 |
| 03663227000894 | CI-Link Unit Programming System |
| 03663227002386 | SOUND PROCESSOR, NEURO2 ZTI C058 |
| 03663227001952 | CI-Link exchange |
| 03663227001846 | PACKING SET, NEURO2 ZTI EXCHANGE BOX C098 |
| 03663227001839 | PACKING SET, NEURO2 ZTI EXCHANGE BOX C094 |