AB Remote

GUDID 07630016878404

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
Primary Device ID07630016878404
NIH Device Record Key79259663-f0e6-4e2e-a1be-a4ab7b098c5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAB Remote
Version Model NumberCI-6058-001
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [Primary]
GS107630016878404 [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

Devices Manufactured by Advanced Bionics AG

07630016878404 - AB Remote 2021-02-22
07630016878404 - AB Remote 2021-02-22
07630016879555 - M Standard Battery 2021-02-22 Velvet Black
07630016880186 - Slim HP AquaMic™2021-02-22 Beige
07630016880193 - Slim HP AquaMic™2021-02-22 Beige
07630016880209 - Slim HP AquaMic™2021-02-22 Gray
07630016880216 - Slim HP AquaMic™2021-02-22 Gray
07630016880223 - Slim HP AquaMic™2021-02-22 Gray
07630016880230 - Slim HP AquaMic™2021-02-22 Gray

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.