FDA.reportPublic FDA data

Mi1250 SYNCHRONY 2 FLEX20 S-Vector Magnet

Primary DI
09008737395490
Brand
Mi1250 SYNCHRONY 2 FLEX20 S-Vector Magnet
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
39549
Catalog number
39577
Device description
'Cochlear Implant
Published
2020-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000025114
P000025122

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000025114COMBI 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
09008737395490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737395490090087373954909008737395490

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 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-29 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-20.2 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify00The sterilized implant may only be stored in this 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
09008737415433Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector MagnetMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2024-10-15
09008737415440Mi1250 SYNCHRONY 2 FLEX34 S-Vector MagnetMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2024-10-15
09008737385422Mi1260 SONATA 2 FLEX20Med-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2020-12-15
09008737385439Mi1260 SONATA 2 FLEX24Med-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2020-12-15
09008737395421Mi1250 SYNCHRONY 2 PIN FLEX24 S-Vector MagnetMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2020-12-15
09008737395438Mi1250 SYNCHRONY 2 FLEX24 S-Vector MagnetMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2020-12-15
09008737395483Mi1250 SYNCHRONY 2 PIN FLEX20 S-Vector MagnetMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2020-12-15
09321502032322NucleusCOCHLEAR LIMITEDPGQ2020-01-25
09008737349219SONNET 2 EAS CPU Me1520 anthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349226SONNET 2 EAS CPU Me1521 anthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349233SONNET 2 EAS CPU Me1522 anthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349240SONNET 2 EAS CPU Me1523 anthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349295SONNET 2 EAS CPU Me1520 ebonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349301SONNET 2 EAS CPU Me1521 ebonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349318SONNET 2 EAS CPU Me1522 ebonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349325SONNET 2 EAS CPU Me1523 ebonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349370SONNET 2 EAS CPU Me1520 blackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349387SONNET 2 EAS CPU Me1521 blackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349394SONNET 2 EAS CPU Me1522 blackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349400SONNET 2 EAS CPU Me1523 blackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349455SONNET 2 EAS CPU Me1520 whiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349462SONNET 2 EAS CPU Me1521 whiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349479SONNET 2 EAS CPU Me1522 whiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349486SONNET 2 EAS CPU Me1523 whiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349530SONNET 2 EAS CPU Me1520 beigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349547SONNET 2 EAS CPU Me1521 beigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349554SONNET 2 EAS CPU Me1522 beigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349561SONNET 2 EAS CPU Me1523 beigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349615SONNET 2 EAS CPU Me1520 nordic greyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18
09008737349622SONNET 2 EAS CPU Me1521 nordic greyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PGQ2019-10-18