| Primary Device ID | 09321502032247 |
| NIH Device Record Key | 43868faa-a069-42f4-8535-b0478b594a4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CUSTOM SOUND SUITE 4.2 CAM |
| Version Model Number | Z538301 |
| Catalog Number | Z538301 |
| Company DUNS | 750551194 |
| Company Name | COCHLEAR LIMITED |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| 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 | |
| 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 | |
| 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 | 09321502032247 [Primary] |
| MCM | IMPLANT, COCHLEAR |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-07-28 |
| Device Publish Date | 2016-09-23 |
| 09321502053082 - Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Straight electrode | 2025-07-15 Cochlear Implant |
| 09321502053099 - Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode | 2025-07-15 Cochlear Implant |
| 09321502053105 - Cochlear™ Nucleus® Nexa™ cochlear implant with Slim 20 electrode | 2025-07-15 Cochlear Implant |
| 09321502053662 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil | 2025-07-15 Hearing Implant Accessory |
| 09321502053679 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil | 2025-07-15 Hearing Implant Accessory |
| 09321502053686 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil | 2025-07-15 Hearing Implant Accessory |
| 09321502053693 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil | 2025-07-15 Hearing Implant Accessory |
| 09321502053709 - Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil | 2025-07-15 Hearing Implant Accessory |