FDA.reportPublic FDA data

SONNET EAS Control Unit anthracite, SP

Primary DI
09008737350734
Brand
SONNET EAS Control Unit anthracite, SP
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
35073
Device description
Audio Processor
Published
2018-06-21
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
P000025078
P000025084
P000025089
P000025092
P000025104
P000025113
P000025115
P000025118
P000025120

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000025078COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025084COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025089COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025092COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025104COMBI 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
09008737350734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737350734090087373507349008737350734

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant systemA battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Dedicated implantation instruments may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
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-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

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Primary DI, Brand, Model table
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09008737308353SONNET FM Battery Pack Cover white308352015-02-28
09008737308360SONNET FM Battery Pack Cover beige308362015-02-28
09008737308377SONNET FM Battery Pack Cover nordic grey308372015-02-28
09008737049997OPUS 2 FM Extension Kit anthracite049992022-09-15
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09008737050030OPUS 2 FM Extension Kit beige050032022-09-15
09008737050047OPUS 2 Children's Extension Kit beige050042022-09-15
09008737050078OPUS 2 FM Extension Kit red050072022-09-15
09008737050085OPUS 2 Children's Extension Kit red050082022-09-15

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Primary DI, Brand, Company table
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