SAMBA 2 52796

GUDID 09008737527969

Remote Control

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control Hearing device remote control
Primary Device ID09008737527969
NIH Device Record Keyc6ac5714-f0a8-4823-a4ed-3638c0014f30
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAMBA 2
Version Model Number52796
Catalog Number52796
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com

Operating and Storage Conditions

Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]
GS109008737527969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System
PFOActive Implantable Bone Conduction Hearing System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [SAMBA 2]

09008737527969Remote Control
09008737526122SAMBA 2 BB User Kit, left
09008737526115SAMBA 2 BB User Kit, right
09008737526030SAMBA 2 Remote (iOS)
09008737525279SAMBA 2 BB AP Unit, left
09008737525262SAMBA 2 BB AP Unit, right
09008737525071SAMBA 2 GO
09008737520472SAMBA 2 Remote (Android)

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