FDA.reportPublic FDA data

Earlens Wireless Updater

Primary DI
08500130070000
Brand
Earlens Wireless Updater
Company
EARLENS CORPORATION
Model
EWU01
Catalog number
EWU01
Device description
Lot Number reflects software assembly/packaging lot number
Published
2017-10-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PLKTympanic Membrane Direct Contact Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLKTympanic Membrane Direct Contact Hearing AidEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08500130070000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08500130070000085001300700008500130070000

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid/implant system programming interface unitA portable, electrically-powered device intended to facilitate the wireless or wired connection of a hearing aid, or the sound processor of a hearing implant system, to a computer for programming of the hearing device with patient-specific settings. It typically consists of a small unit attached to the sound processor or hearing aid. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
611658795
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08500130070192Earlens ELF USBELFW01ELFW012016-09-24
00850013007417Earlens Fidelity SoftwareELF003ELF0032020-10-20
00850013007042Earlens ELF USBELF001ELF0012016-09-24
00850013007295Earlens Fitting Software, USBELF002ELF0022019-05-06
00850013007387Impression DispenserIDG01IDG012023-06-09
00850013007516Earlens Processor, Champagne IPR01CHIPR01CH2023-06-09
00850013007523Earlens Processor, SilverIPR01SIIPR01SI2023-06-09
00850013007530Earlens Processor, BlackIPR01BLIPR01BL2023-06-09
00850013007547Earlens Ear Tip, LeftET01LET01L2023-06-09
00850013007554Earlens Ear Tip, RightET01RET01R2023-06-09
00850013007561Earlens Tympanic Lens, LeftITL01LITL01L2023-06-09
00850013007578Earlens Tympanic Lens, RightITL01RITL01R2023-06-09
00850013007370Medial Impression CartridgesIMC03IMC032021-10-06
00850013007479Soft Medial Mixing TipsIDT04IDT042021-06-22
00850013007509Lateral Mixing TipsIDT05IDT052021-12-03
00850013007493Lateral Impression CartridgesIMC04IMC042021-10-06
00850013007349Earlens Hybrid Impression KitHIK02HIK022020-09-10
00850013007110Earlens Wireless ProgrammerWPUSB01WPUSB012016-09-24
00850013007202Earlens ProcessorIPR01XXIPR01XX2019-05-06
00850013007219Earlens Ear TipET01XET01X2019-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503535519Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535526Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535533Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535540Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535516MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535523MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535530MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535547MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535557Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535564Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
00850013007516Earlens Processor, Champagne EARLENS CORPORATIONPLK2023-06-09
00850013007523Earlens Processor, SilverEARLENS CORPORATIONPLK2023-06-09
00850013007530Earlens Processor, BlackEARLENS CORPORATIONPLK2023-06-09
00850013007547Earlens Ear Tip, LeftEARLENS CORPORATIONPLK2023-06-09
00850013007554Earlens Ear Tip, RightEARLENS CORPORATIONPLK2023-06-09
00850013007561Earlens Tympanic Lens, LeftEARLENS CORPORATIONPLK2023-06-09
00850013007578Earlens Tympanic Lens, RightEARLENS CORPORATIONPLK2023-06-09
00850013007462Earlens ProcessorEARLENS CORPORATIONPLK2021-06-18
00850013007417Earlens Fidelity SoftwareEARLENS CORPORATIONPLK2020-10-20
00850013007202Earlens ProcessorEARLENS CORPORATIONPLK2019-05-06
00850013007219Earlens Ear TipEARLENS CORPORATIONPLK2019-05-06
00850013007226Earlens Ear Tip, BinauralEARLENS CORPORATIONPLK2019-05-06
00850013007233Earlens Processor & Ear TipEARLENS CORPORATIONPLK2019-05-06
00850013007240Earlens Tympanic LensEARLENS CORPORATIONPLK2019-05-06
00850013007257Earlens Tympanic Lens, BinauralEARLENS CORPORATIONPLK2019-05-06
00850013007264Earlens Contact Hearing Solution, Monaural, LeftEARLENS CORPORATIONPLK2019-05-06
00850013007271Earlens Contact Hearing Solution, Monaural, RightEARLENS CORPORATIONPLK2019-05-06
00850013007288Earlens Contact Hearing Solution, BinauralEARLENS CORPORATIONPLK2019-05-06
00850013007295Earlens Fitting Software, USBEARLENS CORPORATIONPLK2019-05-06
08500130070208Earlens ProcessorEARLENS CORPORATIONPLK2019-05-06