FDA.reportPublic FDA data

Medial Impression Cartridge, 3-pack

Primary DI
00850013007356
Brand
Medial Impression Cartridge, 3-pack
Company
EARLENS CORPORATION
Model
IMC03
Catalog number
IMC03
Device description
Medial Impression Cartridge, 3-Pack, IMC03, AS01052
Published
2021-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LDGKit, Earmold, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDGKit, Earmold, ImpressionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013007370PrimaryGS10
00850013007356Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013007370008500130073708500130073700850013007370
00850013007356008500130073568500130073560850013007356

GMDN Terms#

Term, Definition table
TermDefinition
Earmould, custom-madeA custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
611658795
Device count
3
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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E2392956M1Otoform® A softXDreve Otoplastik GmbHLDG2025-01-20
E2393206M1Otoform® A softDreve Otoplastik GmbHLDG2025-01-20
E2395041Otoform® KcDreve Otoplastik GmbHLDG2025-01-13
E2398802AU1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802ST1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802M1Otoform® A softXDreve Otoplastik GmbHLDG2023-12-18
E23988021Otoform® A softX Dreve Otoplastik GmbHLDG2023-10-31
EPRCA0010200otosil IS-2pro3dure medical GmbHLDG2023-10-18
EPRCA0011000otosil PS-1pro3dure medical GmbHLDG2023-10-18
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