Cochlear ™ Nucleus® ABI541 Auditory Brainstem Implant Z246604

GUDID 09321502020404

N/A

COCHLEAR LIMITED

Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly Auditory brainstem implant system electrode array assembly
Primary Device ID09321502020404
NIH Device Record Keyfceea31c-a637-4595-9658-01b20dc430b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCochlear ™ Nucleus® ABI541 Auditory Brainstem Implant
Version Model NumberZ246604
Catalog NumberZ246604
Company DUNS750551194
Company NameCOCHLEAR LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502020404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHEImplant, auditory brainstem

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-10
Device Publish Date2016-09-20

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 [Cochlear]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COCHLEAR
COCHLEAR
79308437 not registered Live/Pending
Cochlear Limited
2021-02-17
COCHLEAR
COCHLEAR
79302761 not registered Live/Pending
Cochlear Limited
2020-12-11
COCHLEAR
COCHLEAR
79226500 5682597 Live/Registered
Cochlear Limited
2017-11-30
COCHLEAR
COCHLEAR
79106109 4615507 Live/Registered
Cochlear Limited
2011-06-30
COCHLEAR
COCHLEAR
76656230 3390528 Live/Registered
COCHLEAR LIMITED
2006-03-03
COCHLEAR
COCHLEAR
76608815 3175621 Live/Registered
Cochlear Limited
2004-08-26
COCHLEAR
COCHLEAR
76583999 3502096 Live/Registered
COCHLEAR LIMITED
2004-03-30
COCHLEAR
COCHLEAR
76583996 3502095 Dead/Cancelled
COCHLEAR LIMITED
2004-03-30
COCHLEAR
COCHLEAR
76583995 3200044 Live/Registered
COCHLEAR LIMITED
2004-03-30
COCHLEAR
COCHLEAR
76583960 3767745 Live/Registered
COCHLEAR LIMITED
2004-03-30
COCHLEAR
COCHLEAR
74278522 1764350 Dead/Cancelled
Cochlear Pty. Limited
1992-05-22

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