FDA.reportPublic FDA data

OPUS 2 DaCapo Extension Kit blue

Primary DI
09008737053819
Brand
OPUS 2 DaCapo Extension Kit blue
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
05381
Device description
Audio Processor Rechargeable Battery Kit
Published
2022-09-16
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
09008737053819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737053819090087370538199008737053819

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. It is typically used during a transport situation (e.g., a neonatal incubator) or when it is designed to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit
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
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
00197420014578Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014592Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014615Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014639Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014653Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014677Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014691Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014714Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014738Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014752Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014776Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017456M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017470M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017494M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017517M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017531M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017555M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017579M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017593M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017616M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017630M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017654M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017999M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018002M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018033M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018057M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018071M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018095M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018118M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018132M BatteryAdvanced Bionics, LLCMCM2026-10-23