RF Cable

GUDID 00840094452404

5.5" Black

Advanced Bionics, LLC

Cochlear implant/auditory brainstem implant external coil cable
Primary Device ID00840094452404
NIH Device Record Keyf34b1fb2-b864-4036-b9c9-680f2f50b2bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameRF Cable
Version Model NumberCI-5415-203
Company DUNS803906382
Company NameAdvanced Bionics, LLC
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

Device Dimensions

Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter
Length14 Centimeter

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100840094452404 [Primary]
GS107630016811111 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-03-19
Device Publish Date2023-01-13

On-Brand Devices [RF Cable]

008400944528934.25" Brown
0084009445287911" Brown
008400944528624.25" Black
0084009445284811" Black
008400944528314.25" Grey
0084009445281711" Grey
008400944528004.25" White
008400944527943.5" White
0084009445278711" White
008400944527704.25" Beige
0084009445275611" Beige
008400944524974.25" Brown
0084009445247312" Brown
0084009445242812" Black
008400944524119.5" Black
008400944524045.5" Black
008400944049605.5" Brown
008400944047933.5" White
0084009440478612" White
008400944047625.5" White
008400944047249.5" Beige

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