FDA.reportPublic FDA data

HiRes 90K™ Replacement Magnet

Primary DI
07630016809910
Brand
HiRes 90K™ Replacement Magnet
Company
Advanced Bionics, LLC
Model
CI-1412
Published
2015-10-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
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
P960058030

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058030CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630016809910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630016809910076300168099107630016809910

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
803906382
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197420014578Zn-Air Battery PakCI-5500-2302026-10-23
00197420014592Zn-Air Battery PakCI-5500-2402026-10-23
00197420014615Zn-Air Battery PakCI-5500-1202026-10-23
00197420014639Zn-Air Battery PakCI-5500-1302026-10-23
00197420014653Zn-Air Battery PakCI-5500-1402026-10-23
00197420014677Zn-Air Battery PakCI-5500-1502026-10-23
00197420014691Zn-Air Battery PakCI-5500-1602026-10-23
00197420014714Zn-Air Battery PakCI-5500-1702026-10-23
00197420014738Zn-Air Battery PakCI-5500-1902026-10-23
00197420014752Zn-Air Battery PakCI-5500-1102026-10-23
00197420014776Zn-Air Battery PakCI-5500-2202026-10-23
00197420017456M Zn-Air Battery PakCI-5501-2802026-10-23
00197420017470M Zn-Air Battery PakCI-5501-2602026-10-23
00197420017494M Zn-Air Battery PakCI-5501-2702026-10-23
00197420017517M Zn-Air Battery PakCI-5501-1202026-10-23
00197420017531M Zn-Air Battery PakCI-5501-1302026-10-23
00197420017555M Zn-Air Battery PakCI-5501-1402026-10-23
00197420017579M Zn-Air Battery PakCI-5501-1502026-10-23
00197420017593M Zn-Air Battery PakCI-5501-1902026-10-23
00197420017616M Zn-Air Battery PakCI-5501-2502026-10-23

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