Nucleus® SmartNav P11799437

GUDID 09321502065917

COCHLEAR LIMITED

Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software Cochlear implant intraoperative electrophysiological analysis software
Primary Device ID09321502065917
NIH Device Record Key1cd073f7-442e-4be3-a848-b816642d77a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNucleus® SmartNav
Version Model NumberV2
Catalog NumberP11799437
Company DUNS750551194
Company NameCOCHLEAR LIMITED
Device Count1
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502065917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-27
Device Publish Date2022-10-19

Devices Manufactured by COCHLEAR LIMITED

09321502009218 - Nucleus2023-11-21 Cochlear Nucleus AOS Forceps for the Contour Advance Electrode
09321502036788 - Nucleus2023-11-03 Nucleus Smart App, (iOS)
09321502043205 - Nucleus2023-11-03 Custom Sound Suite 5.1 CD
09321502043212 - Nucleus2023-11-03 Custom Sound Suite 5.1 Download
09321502043236 - Nucleus2023-11-03 Nucleus Smart App
09321502044899 - Cochlear2023-11-03 Osia™ Fitting Software 2
09321502044905 - Cochlear2023-11-03 Osia™ Fitting Software 2
09321502046138 - Cochlear2023-11-03 Osia Smart App (iOS)

Trademark Results [Nucleus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
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
NUCLEUS
NUCLEUS
88312055 not registered Live/Pending
Nucleus, LLC
2019-02-22
NUCLEUS
NUCLEUS
87980709 5771281 Live/Registered
American Rifle Company, Inc.
2018-01-12
NUCLEUS
NUCLEUS
87945004 not registered Live/Pending
eSATURNUS nv
2018-06-01

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