FDA.reportPublic FDA data

OPUS 2 FM Extension Kit beige

Primary DI
09008737050030
Brand
OPUS 2 FM Extension Kit beige
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
05003
Device description
Audio Processor Battery Kit
Published
2022-09-15
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000025029
P000025039
P000025043
P000025050
P000025051
P000025052
P000025059
P000025104

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000025029COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025039COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025043COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025050COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025051COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025052COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025059COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM
P000025104COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737050030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737050030090087370500309008737050030

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant/auditory brainstem implant external batteryAn external component of a cochlear implant (CI) or auditory brainstem implant system designed to supply direct current (DC) to operate the electrically-powered and dependent components of the system. It is typically worn behind-the-ear (BTE), or is neck- or waist-worn, and may include an on/off switch. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius45 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit113 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity90 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
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
09008737304928SONNET FM Battery Pack Cover anthracite304922015-02-28
09008737308339SONNET FM Battery Pack Cover ebony308332015-02-28
09008737308346SONNET FM Battery Pack Cover black308342015-02-28
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
09008737050009OPUS 2 Children's Extension Kit anthracite050002022-09-15
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
09008737050115OPUS 2 FM Extension Kit blue050112022-09-15

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