Verifit Adapter

Primary DI
09008737415808
Brand
Verifit Adapter
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
41580
Device description
Adapter
Published
2025-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXBHearing Aid, Bone Conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXBHearing Aid, Bone ConductionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737415808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737415808090087374158089008737415808

GMDN Terms#

Term, Definition table
TermDefinition
Bone-conduction hearing aid, head-wornAn electrically-powered, external, acoustic device intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically incorporates a microphone, amplifier, and vibrator mounted or magnetically connected to a head-worn device (e.g., headband or spectacles); it may include positioning and protection devices. The microphone receives sound waves and converts them into electrical signals sent to the vibrator which transmits vibrations, typically through the mastoid bone, to the inner ears for hearing. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-20.2 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300764032
Device count
1
Premarket exempt
true
Manufacturing date on label
true

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