Nucleus Z179839

GUDID 09321502027830

Freedom Snugfit Large (Bg)

COCHLEAR LIMITED

Cochlear implant/auditory brainstem implant sound processor earhook
Primary Device ID09321502027830
NIH Device Record Key7c57516d-2336-4c5b-88e5-723c8c63cd1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNucleus
Version Model NumberZ179839
Catalog NumberZ179839
Company DUNS750551194
Company NameCOCHLEAR LIMITED
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502027830 [Primary]
GS109321502031646 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-08
Device Publish Date2014-09-24

On-Brand Devices [Nucleus]

09321502022668Cochlear Nucleus Aqua Accessory (30)
09321502022651Cochlear Nucleus Aqua Accessory (15)
09321502022644Cochlear Nucleus Aqua Accessory (5)
09321502032322Cochlear EAC200 Series Screwdriver
09321502022583Cochlear Nucleus CR200 Series Charging Kit
09321502022446Cochlear Nucleus Battery Charger (Black)
09321502022439Cochlear Nucleus Battery Charging Kit (Black)
09321502018128Cochlear Nucleus CR100 Series Remote Assistant Charging Kit
09321502017794Cochlear Nucleus CP800 Series Sound Processor Charging Kit (White)
09321502017688Cochlear Nucleus CP800 Series Sound Processor Battery Charger (White)
09321502013598FREEDOM 12V CAR ADAPTOR
09321502013581FREEDOM BTE RECHARGER POWER SUPPLY
09321502013574FREEDOM BTE RECHARGER
09321502013499FREEDOM INTERNATIONAL ADAPTOR PLATES (PLUG PACK)
09321502024679Cochlear Nucleus Lapel Microphone (150 cm)
09321502018098Cochlear Nucleus CP800 Series Lapel Microphone
09321502013246FREEDOM LAPEL MICROPHONE (LAP1)
09321502052139Nucleus® Sound Processor Kit
09321502038775MRI Splint and Bandage Kit
09321502027632NUCLEUS CR120 INTRAOPERATIVE REMOTE ASSISTANT KIT
09321502026673NUCLEUS SERIES, LOOP BOOSTER
09321502022569CR220 Intraoperative Remote Assistant
09321502022552Cochlear Nucleus CR230 Remote Assistant
09321502022545Cochlear Nucleus CR210 Remote Control
09321502022385Cochlear Nucleus CR120 Intraoperative Remote Assistant
09321502022378Cochlear Nucleus CR100 Series Remote Assistant (White)
09321502018104Cochlear Nucleus CR100 Series Remote Assistant (White)
09321502009584Cochlear Nucleus Freedom Programming POD
09321502032612Cochlear Nucleus® CI532 cochlear implant with Slim Modiolar electrode
09321502032599Cochlear Nucleus® CI522 cochlear implant with Slim Straight electrode
09321502030489CAM CP920 DEMO SP
09321502030427NUCLEUS PROCESSOR CARE KIT - CAM
09321502020268Cochlear Nucleus CI422 cochlear implant with Slim Straight Electrode
09321502014564Cochlear Nucleus CI512 cochlear implant with Contour Advance electrode
09321502012089Cochlear Nucleus Hybrid L24 cochlear implant
09321502008891Cochlear Nucleus Freedom Implant with Straight Electrode
09321502007320Cochlear Nucleus Freedom Implant with Contour Advance Electrode
09321502003216CI 11 11 2M
09321502002349COCHLEAR IMPLANT,CI24R (CS)
09321502002318COCHLEAR IMPLANT, MODEL CI24M
09321502041089Cochlear Coil Spacer
09321502033367AQUA+ N22 6M COIL 8CM
09321502033350AQUA+ N22 6M COIL 6CM
09321502033343AQUA+ N22 COIL 8CM
09321502033336AQUA+ N22 COIL 6CM
09321502033312Aqua + 6M Coil 6cm
09321502033305Aqua + 6M Coil 8cm
09321502032759CP900 SERIES N22 COIL INTEGRATED 6M (WHITE)
09321502032742CP900 SERIES N22 COIL INTEGRATED 6M (SMOKE)
09321502032735CP900 SERIES N22 COIL INTEGRATED 6M (MOCHA)

Trademark Results [Nucleus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NUCLEUS
NUCLEUS
98586140 not registered Live/Pending
Good Sportsman Marketing, L.L.C.
2024-06-05
NUCLEUS
NUCLEUS
98571326 not registered Live/Pending
Nucleus AI, LLC
2024-05-28
NUCLEUS
NUCLEUS
98520415 not registered Live/Pending
Nucleus AI, LLC
2024-04-26
NUCLEUS
NUCLEUS
98287985 not registered Live/Pending
NUCLEUS COFFEE TOOLS PTY LTD
2023-11-28
NUCLEUS
NUCLEUS
98117216 not registered Live/Pending
Nucleus Healthcare, LLC
2023-08-04
NUCLEUS
NUCLEUS
98054826 not registered Live/Pending
MAXSIP HC LLC
2023-06-22
NUCLEUS
NUCLEUS
98054775 not registered Live/Pending
MAXSIP HC LLC
2023-06-22
NUCLEUS
NUCLEUS
97642173 not registered Live/Pending
Pro-Ficiency, LLC
2022-10-21
NUCLEUS
NUCLEUS
97509234 not registered Live/Pending
Electrify America, LLC
2022-07-19
NUCLEUS
NUCLEUS
97272468 not registered Live/Pending
HighRes Biosolutions Inc.,
2022-02-17
NUCLEUS
NUCLEUS
90815685 not registered Live/Pending
Control 3, LLC
2021-07-07
NUCLEUS
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.