FDA.reportPublic FDA data

AquaMic™ 3D Color Cap

Primary DI
07630016857331
Brand
AquaMic™ 3D Color Cap
Company
Advanced Bionics AG
Model
CI-7130-220
Device description
Velvet Black
Published
2018-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
P960058129

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058129CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630016857331PrimaryGS10
07630016866487Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630016857331076300168573317630016857331
07630016866487076300168664877630016866487

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system coil cover/spacerA small device intended to be used as a cover/cap for a cochlear implant system coil, and/or to maintain the position of the coil casing. It is typically supplied with a removal tool. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(661)362-1400xxx@xxx.xxx

Regulatory Flags#

DUNS number
485262658
Device count
2
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630016880575Slim HP Color Cap CI-7131-0012021-02-08
07630016880582Slim HP Color Cap CI-7131-0022021-02-08
07630016880599Slim HP Color Cap CI-7131-0032021-02-11
07630016880605Slim HP Color Cap CI-7131-0042021-02-11
07630016880612Slim HP Color Cap CI-7131-0052021-02-11
07630016880629Slim HP Color Cap CI-7131-0062021-02-11
07630016880636Slim HP Color Cap CI-7131-0072021-02-11
07630016880650Slim HP Color Cap CI-7131-0092021-02-11
07630016880667Slim HP Color Cap CI-7131-0102021-02-11
07630016880674Slim HP Color Cap CI-7132-0012021-02-11
07630016880681Slim HP Color Cap CI-7132-0022021-02-12
07630016880698Slim HP Color Cap CI-7132-0032021-02-12
07630016880704Slim HP Color Cap CI-7132-0042021-02-12
07630016880919Slim HP Color Cap CI-7131-0112021-02-11
07630016881718Slim HP Color Cap CI-7132-0052021-02-12
07630016871801UHP 3DCI-53162019-08-05
07630016871825AquaMic™3D CI-53172019-08-15
07630016873959UHP 3D PlusCI-53182019-08-07
07630016878404AB Remote CI-6058-0012021-02-12
07630016880186Slim HP AquaMic™CI-5321-0092021-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09321502072250Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072267Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072274Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR 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
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00197420012703Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012727Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
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00197420012789Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012802Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012826Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012840Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012864Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012888Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012901Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012925Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012949Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012963Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012987Naida™ CI M90Advanced Bionics CorporationMCM2024-12-16
00197420013007Naida™ CI M90Advanced Bionics CorporationMCM2024-12-16