HiFocus™ Mid-Scala Electrode Instrument Kit

GUDID 07630016815249

Advanced Bionics AG

Cochlear implant system
Primary Device ID07630016815249
NIH Device Record Key7adf767e-ea8c-4c5f-9d9a-16147199a8b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHiFocus™ Mid-Scala Electrode Instrument Kit
Version Model NumberCI-4508
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 Kittrue
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
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 Identifiers

Device Issuing AgencyDevice ID
GS107630016815249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


[07630016815249]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [HiFocus™ Mid-Scala Electrode Instrument Kit]

07630016850554CI-4508
07630016815249CI-4508

Trademark Results [HiFocus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HIFOCUS
HIFOCUS
78774068 3747825 Live/Registered
KJELLBERG-STIFTUNG
2005-12-15
HIFOCUS
HIFOCUS
75631254 2427427 Live/Registered
ADVANCED BIONICS AG
1999-02-01

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