SAMBA 2 52047

GUDID 09008737520472

SAMBA 2 Remote (Android)

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

Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software
Primary Device ID09008737520472
NIH Device Record Key48b5ae1d-f52b-434e-8cf0-f52825187db0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAMBA 2
Version Model Number52047
Catalog Number52047
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

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

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]
GS109008737520472 [Primary]

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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