| Primary Device ID | 09321502060370 |
| NIH Device Record Key | 1ea4134d-3156-4849-a70d-1be9c6dfbb17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cochlear SoftWear™ Pad |
| Version Model Number | P793408 |
| Catalog Number | P793408 |
| Company DUNS | 750551194 |
| Company Name | COCHLEAR LIMITED |
| Device Count | 5 |
| 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 | false |
| 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(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09321502034968 [Primary] |
| GS1 | 09321502060370 [Unit of Use] |
| 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 | 2021-03-08 |
| Device Publish Date | 2021-02-26 |
| 09321502009218 - Nucleus | 2023-11-21 Cochlear Nucleus AOS Forceps for the Contour Advance Electrode |
| 09321502036788 - Nucleus | 2023-11-03 Nucleus Smart App, (iOS) |
| 09321502043205 - Nucleus | 2023-11-03 Custom Sound Suite 5.1 CD |
| 09321502043212 - Nucleus | 2023-11-03 Custom Sound Suite 5.1 Download |
| 09321502043236 - Nucleus | 2023-11-03 Nucleus Smart App |
| 09321502044899 - Cochlear | 2023-11-03 Osia™ Fitting Software 2 |
| 09321502044905 - Cochlear | 2023-11-03 Osia™ Fitting Software 2 |
| 09321502046138 - Cochlear | 2023-11-03 Osia Smart App (iOS) |