FDA.reportPublic FDA data

Mi1000 MED-EL CONCERT +FLEX28

Primary DI
09008737083632
Brand
Mi1000 MED-EL CONCERT +FLEX28
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
08363
Catalog number
08842
Device description
Cochlear Implant
Published
2014-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCMImplant, Cochlear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000025050
P000025053
P000025055
P000025056
P000025057
P000025061
P000025063
P000025064
P000025065
P000025066
P000025069
P000025071
P000025072
P000025073
P000025074
P000025076
P000025122

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000025050COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025053COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025055COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025056COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025057COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025061COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025063COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025064COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025065COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025066COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025069COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025071COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025072COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025073COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025074COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025076COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025122COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737083632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737083632090087370836329008737083632

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 Temperature-20 Degrees Celsius55 Degrees Celsius
Handling Environment Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit
Special Storage Condition, Specify00may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date

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
Manufacturing date on label
true
Expiration date on label
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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