FDA.reportPublic FDA data

UHP 3D Color Cap

Primary DI
00840094405486
Brand
UHP 3D Color Cap
Company
Advanced Bionics, LLC
Model
CI-7129-390
Device description
Caribbean Pirate
Published
2022-12-09
Public version status
Update
Distribution status
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
07630016861659PreviousGS10
00840094405486PrimaryGS10
07630016866456Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
07630016861659076300168616597630016861659
00840094405486008400944054868400944054860840094405486
07630016866456076300168664567630016866456

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant/auditory brainstem implant external coil cover/spacerA small device intended to be used as a cover/cap for the external coil of a cochlear implant (CI) or auditory brainstem implant system, 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

Contacts#

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

Regulatory Flags#

DUNS number
803906382
Device count
2
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840094413061Naida CI Q30CI-5260-1202026-10-22
00840094414891Naida CI Q30CI-5260-1202026-10-22
00840094419810Naida CI Q30CI-5260-1402026-10-22
00840094421783Naida CI Q30CI-5260-1402026-10-22
00840094427433Naida CI Q30CI-5260-1502026-10-22
00840094431072Naida CI Q30CI-5260-1502026-10-22
00840094433663Naida CI Q90CI-5280-1202026-10-22
00840094433687Naida CI Q90CI-5280-1202026-10-22
00840094433908Naida CI Q90CI-5280-1302026-10-22
00840094433953Naida CI Q90CI-5280-1302026-10-22
00840094434011Naida CI Q90CI-5280-1402026-10-22
00840094434073Naida CI Q90CI-5280-1402026-10-22
00840094434103Naida CI Q90CI-5280-1502026-10-22
00840094434134Naida CI Q90CI-5280-1502026-10-22
00840094434202Naida CI Q90CI-5280-1602026-10-22
00840094435414Naida CI Q90CI-5280-1602026-10-22
00840094445499Naida CI Q90CI-5280-1702026-10-22
00840094445505Naida CI Q90CI-5280-1702026-10-22
00840094445512Naida CI Q90CI-5280-1902026-10-22
00840094445574Naida CI Q90CI-5280-1902026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840094413061Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094414891Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094419810Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094421783Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094427433Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094431072Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094433663Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094433687Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094433908Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094433953Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434011Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434073Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434103Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434134Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434202Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094435414Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445499Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445505Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445512Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445574Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094467033Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094467064Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094468924Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094480643Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094481138Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094481510Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094482548Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094483811Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094486362Naida CI M90Advanced Bionics, LLCMCM2026-10-22
00840094486379Naida CI M90Advanced Bionics, LLCMCM2026-10-22