Slim HP AquaMic™

GUDID 07630016880315

Brown

Advanced Bionics AG

Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil Cochlear implant system coil
Primary Device ID07630016880315
NIH Device Record Key4e065fab-2599-4ee3-8c5b-1555b4320830
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlim HP AquaMic™
Version Model NumberCI-5321-015
Company DUNS485262658
Company NameAdvanced Bionics AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Device Dimensions

Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch
Length42 Inch

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]
GS107630016880315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-12

On-Brand Devices [Slim HP AquaMic™]

07630016880179Beige
07630016880162Beige
07630016880315Brown
07630016880308Brown
07630016880292Brown
07630016880285Brown
07630016880278Black
07630016880261Black
07630016880254Black
07630016880247Black
07630016880230Gray
07630016880223Gray
07630016880216Gray
07630016880209Gray
07630016880193Beige
07630016880186Beige

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