FDA.reportPublic FDA data

Amadé Hi, Terra Brown, Right

Primary DI
09008738504631
Brand
Amadé Hi, Terra Brown, Right
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
50463
Device description
Audio Processor
Published
2014-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
P990052022

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990052022VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEMMed-El Elektromedizinische Gerate GmbH2000-08-31MPV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008738504631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008738504631090087385046319008738504631

GMDN Terms#

Term, Definition table
TermDefinition
Partially-implantable middle ear implant systemA battery-powered assembly of devices intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, to the middle ear. It primarily consists of an external microphone and a vibrator implanted in the middle ear that is coupled with an ossicle (middle ear bone) or the oval window. The microphone receives sound waves and converts them into electrical signals (radio waves) which are sent to the vibrator for the transmission of vibrations to the middle ear bones to activate the auditory pathway. A middle ear implant (MEI) is typically used to treat sensorineural hearing loss (SNHL) or hearing impairment due to middle and/or outer ear obstructive pathologies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09008737346898ADHEAR Adhesive Adapters, beige, 15 pcs.346892018-06-27
09008737346904ADHEAR Adhesive Adapters, brown, 15 pcs.346902018-06-27
09008737346911ADHEAR Headband, black346912018-06-27
09008737353247ADHEAR Headband, beige353242018-06-27
09008737353254ADHEAR Headband, pink353252018-06-27
09008737353261ADHEAR Headband, blue353262018-06-27
09008737396060ADHEAR Headband, black, bilateral396062019-11-08
09008737396077ADHEAR Headband, beige, bilateral396072019-11-08
09008737396084ADHEAR Headband, pink, bilateral396082019-11-08
09008737396091ADHEAR Headband, blue, bilateral396092019-11-08
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

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
09008737526481SAMBA 2 Lo PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
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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
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