FDA.reportPublic FDA data

Chorus Protective Case

Primary DI
07630016863875
Brand
Chorus Protective Case
Company
Advanced Bionics AG
Model
CI-7432
Published
2019-03-15
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
P960058132

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058132CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630016863875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630016863875076300168638757630016863875

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system waterproof kitA collection of non-sterile devices intended to be used with a cochlear implant system to protect the externally worn components in wet and/or rugged environments (e.g. for swimming, showering). The set typically consists of a sound processor case, waterproof microphone, and a connecting cable. 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
1
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
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