FDA.reportPublic FDA data

SONNET 2 EAS CPU Me1520 white

Primary DI
09008737349455
Brand
SONNET 2 EAS CPU Me1520 white
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
34945
Device description
Audio Processor
Published
2019-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCMImplant, Cochlear
PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3
PGQCochlear Implant With Combined Electrical Stimulation And Acoustic AmplificationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000025112
P000025113
P000025115
P000025118
P000025120

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000025112COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025113COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025115COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025118COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025120COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737349455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737349455090087373494559008737349455

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system sound processorThe non-sterile external portion of a cochlear implant system [cochlear implant (CI)] that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transmitted to the implantable portion of the device, via a coil, for the partial restoration of auditory sensation in a profoundly deaf person. Also known as a speech processor, it is typically worn like a behind-the-ear (BTE) hearing aid.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 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
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
09008737461379SONNET Battery Pack Cover Standard Pro, AnthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461386SONNET Battery Pack Cover Standard Pro, EbonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461393SONNET Battery Pack Cover Standard Pro, Nordic GrayMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461409SONNET Battery Pack Cover Standard Pro, BeigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461416SONNET Battery Pack Cover Standard Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461423SONNET Battery Pack Cover Standard Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461485SONNET Battery Pack Cover Micro Pro, AnthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461492SONNET Battery Pack Cover Micro Pro, EbonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461508SONNET Battery Pack Cover Micro Pro, Nordic GrayMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461515SONNET Battery Pack Cover Micro Pro, BeigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461522SONNET Battery Pack Cover Micro Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461539SONNET Battery Pack Cover Micro Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
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