FDA.reportPublic FDA data

N52 Magnet

Primary DI
07630016854217
Brand
N52 Magnet
Company
Advanced Bionics AG
Model
CI-7522
Published
2018-05-14
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
P960058125

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058125CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840094452916PrimaryGS10
07630016854217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840094452916008400944529168400944529160840094452916
07630016854217076300168542177630016854217

GMDN Terms#

Term, Definition table
TermDefinition
Assistive object fixation magnetA device intended to be used by a person with a disability for the purpose of fixing an object being used by the person in a locked or secure position. This device is magnetic and designed in various configurations where the magnet provides the holding force.

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
00197420015179PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015186PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015216PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015223PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015254PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015278PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015292PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015315PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015339PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015353PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015377PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015407PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015421PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015445PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015469PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015483PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015506PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015520PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015544PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015568PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015582PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015827PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015858PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015872PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015896PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015964PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015995PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016008PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016022PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016046PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26