FDA.reportPublic FDA data

SAMBA 2 Lo PoM, right

Primary DI
09008737526481
Brand
SAMBA 2 Lo PoM, right
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
52648
Device description
Audio Processor
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MPVImplant, Hearing, Active, Middle Ear, Partially Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPVImplant, Hearing, Active, Middle Ear, Partially ImplantedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990052026

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990052026VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEMMed-El Elektromedizinische Gerate GmbH2000-08-31MPV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737526481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737526481090087375264819008737526481

GMDN Terms#

Term, Definition table
TermDefinition
Partially-implantable middle ear implant system sound processorThe non-sterile external portion of a partially-implantable middle ear implant system that typically consists of a battery-powered microphone, signal analysis and filtering unit, radio-frequency (RF) modulator and amplifier, and an RF transmitter and antenna. These components receive sound waves from the environment, convert them into electrical signals (radio waves), and transmit the signals to the implantable portion of the system which activates the auditory pathway by vibrating the ossicles (middle ear bones).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-633-3524implants.us@medel.com

Regulatory Flags#

DUNS number
300764032
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09008737461379SONNET Battery Pack Cover Standard Pro, Anthracite461372026-02-26
09008737461386SONNET Battery Pack Cover Standard Pro, Ebony461382026-02-26
09008737461393SONNET Battery Pack Cover Standard Pro, Nordic Gray461392026-02-26
09008737461409SONNET Battery Pack Cover Standard Pro, Beige461402026-02-26
09008737461416SONNET Battery Pack Cover Standard Pro, White461412026-02-26
09008737461423SONNET Battery Pack Cover Standard Pro, Black461422026-02-26
09008737461485SONNET Battery Pack Cover Micro Pro, Anthracite461482026-02-26
09008737461492SONNET Battery Pack Cover Micro Pro, Ebony461492026-02-26
09008737461508SONNET Battery Pack Cover Micro Pro, Nordic Gray461502026-02-26
09008737461515SONNET Battery Pack Cover Micro Pro, Beige461512026-02-26
09008737461522SONNET Battery Pack Cover Micro Pro, White461522026-02-26
09008737461539SONNET Battery Pack Cover Micro Pro, Black461532026-02-26
09008737583262SoftGrip Forceps583262021-04-09
09008737415808Verifit Adapter415802025-11-17
09008737002848Surgical Claw angled002842014-09-22
09008737455712AudioLink XT Kit455712025-02-26
09008737458904AudioLink XT Core Kit458902025-02-26
09008737415433Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet41543415472024-10-15
09008737415440Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet41544415482024-10-15
09008737416218Insertion Electrode FLEX34416212024-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09008737525286SAMBA 2 Hi AP unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525293SAMBA 2 Hi AP unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525309SAMBA 2 Lo AP unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525316SAMBA 2 Lo AP unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525347SAMBA 2 Hi PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525354SAMBA 2 Hi PoM, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525361SAMBA 2 Lo PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525378SAMBA 2 Lo PoM, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526139SAMBA 2 Hi User Kit, RightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526146SAMBA 2 Hi User Kit, LeftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526153SAMBA 2 Lo User Kit, RightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526160SAMBA 2 Lo User Kit, LeftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526399SAMBA 2 Hi AP unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526405SAMBA 2 Hi AP unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526412SAMBA 2 Lo AP unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526429SAMBA 2 Lo AP unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526450SAMBA 2 Hi PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526467SAMBA 2 Hi PoM, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526474SAMBA 2 Lo PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737532925SAMBA 2 GO w/o manualsMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-11-16
M737M31101MAXUMOtotronix, LLCMPV2022-03-29
M737M31991MAXUMOtotronix, LLCMPV2022-03-29
M737M53031MAXUMOtotronix, LLCMPV2022-03-29
09008737520472SAMBA 2 Remote (Android)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737525033SYMFIT 8.0 DownloadMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737525071SAMBA 2 GOMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737525811SYMFIT 8.0 DVDMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737525859SYMFIT 8.0 USBMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737526030SAMBA 2 Remote (iOS)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737527969Remote ControlMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08