FDA.reportPublic FDA data

OPUS 2 Children's Extension Kit red

Primary DI
09008737050085
Brand
OPUS 2 Children's Extension Kit red
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
05008
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
09008737050085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737050085090087370500859008737050085

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 Temperature-20 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit113 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Temperature10 Degrees Celsius45 Degrees Celsius

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
09008737346898ADHEAR Adhesive Adapters, beige, 15 pcs.346892018-06-27
09008737346904ADHEAR Adhesive Adapters, brown, 15 pcs.346902018-06-27
09008737346911ADHEAR Headband, black346912018-06-27
09008737353247ADHEAR Headband, beige353242018-06-27
09008737353254ADHEAR Headband, pink353252018-06-27
09008737353261ADHEAR Headband, blue353262018-06-27
09008737396060ADHEAR Headband, black, bilateral396062019-11-08
09008737396077ADHEAR Headband, beige, bilateral396072019-11-08
09008737396084ADHEAR Headband, pink, bilateral396082019-11-08
09008737396091ADHEAR Headband, blue, bilateral396092019-11-08
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

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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09321502072243Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072250Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072267Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072274Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502053082Cochlear® Nucleus® Nexa™ cochlear implant with Slim Straight electrodeCOCHLEAR LIMITEDMCM2025-07-07
09321502053099Cochlear® Nucleus® Nexa™ cochlear implant with Slim Modiolar electrodeCOCHLEAR LIMITEDMCM2025-07-07
09321502053105Cochlear® Nucleus® Nexa™ cochlear implant with Slim 20 electrodeCOCHLEAR LIMITEDMCM2025-07-07
09321502069847Cochlear® Nucleus® Nexa™ cochlear implantCOCHLEAR LIMITEDMCM2025-07-07
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00197420012567Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012581Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012604Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012628Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012642Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012666Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012680Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16