HiRes™ Ultra 3D CI HiFocus™ MS Electrode

GUDID 00840094455993

Advanced Bionics, LLC

Cochlear implant system electrode array assembly
Primary Device ID00840094455993
NIH Device Record Key2f213deb-9aa3-448d-bbff-2f50538d3fc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameHiRes™ Ultra 3D CI HiFocus™ MS Electrode
Version Model NumberCI-1601-04
Company DUNS803906382
Company NameAdvanced Bionics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840094455993 [Primary]
GS107630016877995 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-19
Device Publish Date2022-12-09

Devices Manufactured by Advanced Bionics, LLC

00840094481640 - HiRes™ Ultra CI HiFocus™ SlimJ Electrode2024-08-26
00840094483156 - HiRes™ Ultra CI HiFocus™ MS Electrode2024-08-26
00840094455962 - HiRes™ Ultra CI HiFocus™ MS Electrode2024-08-19
00840094455993 - HiRes™ Ultra 3D CI HiFocus™ MS Electrode2024-08-19
00840094455993 - HiRes™ Ultra 3D CI HiFocus™ MS Electrode2024-08-19
00840094456020 - HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode2024-08-19
00840094448247 - Auria™ PowerCel™ Slim2024-07-23 Silver Metallic
00840094448254 - Auria™ PowerCel™ Slim2024-07-23 Beige
00840094446571 - Naída™ CI M30 Sound Processor2024-05-29 Resin Beige

Trademark Results [HiRes]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HIRES
HIRES
86321816 4681668 Live/Registered
TOPSIL GLOBAL WAFERS A/S
2014-06-26
HIRES
HIRES
79214921 not registered Dead/Abandoned
Maschinenfabrik Reinhausen GmbH
2016-07-28
HIRES
HIRES
79050788 3598674 Live/Registered
Applied Materials GmbH & Co. KG
2008-02-06
HIRES
HIRES
78811996 3251053 Dead/Cancelled
Seismic Ventures, Inc.
2006-02-10
HIRES
HIRES
78692099 3365646 Dead/Cancelled
TA PENG HUANG
2005-08-13
HIRES
HIRES
78674243 3195941 Live/Registered
DR PEPPER/SEVEN UP, INC.
2005-07-20
HIRES
HIRES
78510853 3271510 Dead/Cancelled
Topsil Semiconductor Materials A/S
2004-11-03
HIRES
HIRES
78351647 2917467 Live/Registered
DR PEPPER/SEVEN UP, INC.
2004-01-14
HIRES
HIRES
78174387 not registered Dead/Abandoned
ADVANCED BIONICS, LLC
2002-10-15
HIRES
HIRES
78135779 2861301 Live/Registered
ADVANCED BIONICS AG
2002-06-14
HIRES
HIRES
75697038 2418758 Dead/Cancelled
STORA ENSO OYJ
1999-05-04
HIRES
HIRES
74099496 1671998 Dead/Cancelled
Cadbury Beverages B.V.
1990-09-24

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