Nucleus® 7 Aqua + Coil P789747

GUDID 09321502039079

8 cm (3")

COCHLEAR LIMITED

Cochlear implant system waterproof kit
Primary Device ID09321502039079
NIH Device Record Key43cd4870-271e-4055-a4cf-3449c2f7fbcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNucleus® 7 Aqua + Coil
Version Model NumberP789747
Catalog NumberP789747
Company DUNS750551194
Company NameCOCHLEAR LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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

Device Dimensions

Length8 Centimeter
Device Size Text, specify0
Length8 Centimeter
Device Size Text, specify0
Length8 Centimeter
Device Size Text, specify0
Length8 Centimeter
Device Size Text, specify0
Length8 Centimeter
Device Size Text, specify0
Length8 Centimeter
Device Size Text, specify0
Length8 Centimeter
Device Size Text, specify0
Length8 Centimeter
Device Size Text, specify0
Length8 Centimeter
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502039079 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-03
Device Publish Date2017-06-28

On-Brand Devices [Nucleus® 7 Aqua + Coil]

093215020390866 cm (2 1/2")
093215020390798 cm (3")

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

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