Recess Gauge for HiRes 90K™

GUDID 07630016837135

Advanced Bionics AG

Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system
Primary Device ID07630016837135
NIH Device Record Key34bbae02-ce3e-4b0c-8fe4-905902f402b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameRecess Gauge for HiRes 90K™
Version Model NumberCI-4330
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
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
GS107630016809934 [Primary]
GS107630016837135 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

Moist Heat or Steam Sterilization


[07630016837135]

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

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07630016875144 - 3D Magnet2022-04-08 Max
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07630016871801 - UHP 3D2021-10-19

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