Auria™ Headpiece

GUDID 07630016808210

Beige

Advanced Bionics AG

Cochlear implant system coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable Cochlear implant/auditory brainstem implant coil cable
Primary Device ID07630016808210
NIH Device Record Key404896c8-44e8-4019-85d0-9c4b35f071f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuria™ Headpiece
Version Model NumberCI-5304-315
Company DUNS485262658
Company NameAdvanced Bionics AG
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx

Device Dimensions

Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter
Length30 Centimeter

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107630016808210 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-08

On-Brand Devices [Auria™ Headpiece]

07630016826481Silver Metallic
07630016808210Beige
07630016808203Beige
07630016808197Beige
07630016808159Silver Metallic
07630016808142Silver Metallic
07630016808135Silver Metallic
07630016808128Dark Sienna Metallic
07630016808104Dark Sienna Metallic
07630016805899Beige
07630016805882Silver Metallic
07630016805875Dark Sienna Metallic
07630016805851Dark Sienna Metallic
07630016805844Beige
07630016805820Dark Sienna Metallic

Trademark Results [Auria]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AURIA
AURIA
98198408 not registered Live/Pending
Boecore, LLC
2023-09-26
AURIA
AURIA
98094011 not registered Live/Pending
AURIA HEALTH LLC
2023-07-20
AURIA
AURIA
98003010 not registered Live/Pending
Drako Limited
2023-05-18
AURIA
AURIA
97505075 not registered Live/Pending
Pattern Inc.
2022-07-15
AURIA
AURIA
97106699 not registered Live/Pending
Namida Lab, Inc.
2021-11-03
AURIA
AURIA
87890593 not registered Live/Pending
Indigo Books & Music Inc.
2018-04-24
AURIA
AURIA
85497091 not registered Dead/Abandoned
WaveMachine Labs, Inc.
2011-12-16
AURIA
AURIA
85228865 4078109 Dead/Cancelled
AURIA SOLAR CO., LTD.
2011-01-28
AURIA
AURIA
85227232 not registered Dead/Abandoned
EQD Corporation
2011-01-26
AURIA
AURIA
79219561 5582777 Live/Registered
TERRAMARK MARKENCREATION GmbH
2017-09-05
AURIA
AURIA
79068396 3850162 Live/Registered
Eternit Österreich GmbH
2009-03-24
AURIA
AURIA
78174436 2915130 Live/Registered
ADVANCED BIONICS AG
2002-10-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.