Slim HP Color Cap

GUDID 07630016886102

Large Velvet Black

Advanced Bionics AG

Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer Cochlear implant system coil cover/spacer
Primary Device ID07630016886102
NIH Device Record Key38a041f1-ae60-424d-a728-b62ca5d3b0a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlim HP Color Cap
Version Model NumberCI-7132-004
Company DUNS485262658
Company NameAdvanced Bionics AG
Device Count2
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

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016880704 [Primary]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]
GS107630016886102 [Unit of Use]

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 Color Cap ]

07630016885976Blue Ocean
07630016885969Lava Red
07630016886065Resin Black
07630016886072Large Sand Beige
07630016886058Alpine White
07630016886041Precious Pink
07630016880643Caribbean Pirate
07630016886027Velvet Black
07630016886010Silver Gray
07630016886003Chestnut
07630016885990Sand Beige
07630016885983Majesty Purple
07630016886171Large Resin Black
07630016886102Large Velvet Black
07630016886096Large Silver Gray
07630016886089Large Chestnut

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