Nucleus Z285905
GUDID 09321502023078
Cochlear Nucleus CP900 Series Magnet (1 M, Smoke)
COCHLEAR LIMITED
Cochlear implant system coil| Primary Device ID | 09321502023078 |
| NIH Device Record Key | 9ac1753c-e613-485a-a91a-55d7279c0817 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nucleus |
| Version Model Number | Z285905 |
| Catalog Number | Z285905 |
| 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 | true |
| 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 |
Customer Support Contacts
| 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 | |
| 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 Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09321502023078 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970051
FDA Product Code
| MCM | IMPLANT, COCHLEAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-10-19 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [Nucleus]
| 09321502022668 | Cochlear Nucleus Aqua Accessory (30) |
| 09321502022651 | Cochlear Nucleus Aqua Accessory (15) |
| 09321502022644 | Cochlear Nucleus Aqua Accessory (5) |
| 09321502032322 | Cochlear EAC200 Series Screwdriver |
| 09321502022583 | Cochlear Nucleus CR200 Series Charging Kit |
| 09321502022446 | Cochlear Nucleus Battery Charger (Black) |
| 09321502022439 | Cochlear Nucleus Battery Charging Kit (Black) |
| 09321502018128 | Cochlear Nucleus CR100 Series Remote Assistant Charging Kit |
| 09321502017794 | Cochlear Nucleus CP800 Series Sound Processor Charging Kit (White) |
| 09321502017688 | Cochlear Nucleus CP800 Series Sound Processor Battery Charger (White) |
| 09321502013598 | FREEDOM 12V CAR ADAPTOR |
| 09321502013581 | FREEDOM BTE RECHARGER POWER SUPPLY |
| 09321502013574 | FREEDOM BTE RECHARGER |
| 09321502013499 | FREEDOM INTERNATIONAL ADAPTOR PLATES (PLUG PACK) |
| 09321502024679 | Cochlear Nucleus Lapel Microphone (150 cm) |
| 09321502018098 | Cochlear Nucleus CP800 Series Lapel Microphone |
| 09321502013246 | FREEDOM LAPEL MICROPHONE (LAP1) |
| 09321502052139 | Nucleus® Sound Processor Kit |
| 09321502038775 | MRI Splint and Bandage Kit |
| 09321502027632 | NUCLEUS CR120 INTRAOPERATIVE REMOTE ASSISTANT KIT |
| 09321502026673 | NUCLEUS SERIES, LOOP BOOSTER |
| 09321502022569 | CR220 Intraoperative Remote Assistant |
| 09321502022552 | Cochlear Nucleus CR230 Remote Assistant |
| 09321502022545 | Cochlear Nucleus CR210 Remote Control |
| 09321502022385 | Cochlear Nucleus CR120 Intraoperative Remote Assistant |
| 09321502022378 | Cochlear Nucleus CR100 Series Remote Assistant (White) |
| 09321502018104 | Cochlear Nucleus CR100 Series Remote Assistant (White) |
| 09321502009584 | Cochlear Nucleus Freedom Programming POD |
| 09321502032612 | Cochlear Nucleus® CI532 cochlear implant with Slim Modiolar electrode |
| 09321502032599 | Cochlear Nucleus® CI522 cochlear implant with Slim Straight electrode |
| 09321502030489 | CAM CP920 DEMO SP |
| 09321502030427 | NUCLEUS PROCESSOR CARE KIT - CAM |
| 09321502020268 | Cochlear Nucleus CI422 cochlear implant with Slim Straight Electrode |
| 09321502014564 | Cochlear Nucleus CI512 cochlear implant with Contour Advance electrode |
| 09321502012089 | Cochlear Nucleus Hybrid L24 cochlear implant |
| 09321502008891 | Cochlear Nucleus Freedom Implant with Straight Electrode |
| 09321502007320 | Cochlear Nucleus Freedom Implant with Contour Advance Electrode |
| 09321502003216 | CI 11 11 2M |
| 09321502002349 | COCHLEAR IMPLANT,CI24R (CS) |
| 09321502002318 | COCHLEAR IMPLANT, MODEL CI24M |
| 09321502041089 | Cochlear Coil Spacer |
| 09321502033367 | AQUA+ N22 6M COIL 8CM |
| 09321502033350 | AQUA+ N22 6M COIL 6CM |
| 09321502033343 | AQUA+ N22 COIL 8CM |
| 09321502033336 | AQUA+ N22 COIL 6CM |
| 09321502033312 | Aqua + 6M Coil 6cm |
| 09321502033305 | Aqua + 6M Coil 8cm |
| 09321502032759 | CP900 SERIES N22 COIL INTEGRATED 6M (WHITE) |
| 09321502032742 | CP900 SERIES N22 COIL INTEGRATED 6M (SMOKE) |
| 09321502032735 | CP900 SERIES N22 COIL INTEGRATED 6M (MOCHA) |
Trademark Results [Nucleus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUCLEUS 98586140 not registered Live/Pending |
Good Sportsman Marketing, L.L.C. 2024-06-05 |
 NUCLEUS 98571326 not registered Live/Pending |
Nucleus AI, LLC 2024-05-28 |
 NUCLEUS 98520415 not registered Live/Pending |
Nucleus AI, LLC 2024-04-26 |
 NUCLEUS 98287985 not registered Live/Pending |
NUCLEUS COFFEE TOOLS PTY LTD 2023-11-28 |
 NUCLEUS 98117216 not registered Live/Pending |
Nucleus Healthcare, LLC 2023-08-04 |
 NUCLEUS 98054826 not registered Live/Pending |
MAXSIP HC LLC 2023-06-22 |
 NUCLEUS 98054775 not registered Live/Pending |
MAXSIP HC LLC 2023-06-22 |
 NUCLEUS 97642173 not registered Live/Pending |
Pro-Ficiency, LLC 2022-10-21 |
 NUCLEUS 97509234 not registered Live/Pending |
Electrify America, LLC 2022-07-19 |
 NUCLEUS 97272468 not registered Live/Pending |
HighRes Biosolutions Inc., 2022-02-17 |
 NUCLEUS 90815685 not registered Live/Pending |
Control 3, LLC 2021-07-07 |
 NUCLEUS 90711427 not registered Live/Pending |
NTT DATA, Inc. 2021-05-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.