Recess Marking Template for HiRes 90K™

GUDID 07630016837104

Advanced Bionics AG

Cochlear implant system
Primary Device ID07630016837104
NIH Device Record Key90193602-b3ea-4166-b5b7-9cef69a3aed9
Commercial Distribution StatusIn Commercial Distribution
Brand NameRecess Marking Template for HiRes 90K™
Version Model NumberCI-4430
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
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
GS107630016809989 [Primary]
GS107630016837104 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


[07630016837104]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-08

Devices Manufactured by Advanced Bionics AG

07630016894015 - M Standard battery 2024-03-20
07630016894022 - M Standard battery 2024-03-20 Precious pink
07630016894039 - M Standard battery 2024-03-20 Blue ocean
07630016894046 - M Standard battery 2024-03-20 Majesty purple
07630016875144 - 3D Magnet2022-04-08 Max
07630016875557 - 3D Headpiece Magnet Kit2022-04-08
07630016875625 - 3D Magnet2022-04-08 Plus
07630016871801 - UHP 3D2021-10-19

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