FDA.report

Widex

Primary DI
05706069727005
Brand
Widex
Company
Widex A/S
Model
E-PA
Catalog number
8 400 0101 854
Device description
Widex EVOKE E-PA (Tech Black S-110 ) RC coil
Published
2018-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05706069727005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05706069727005057060697270055706069727005

GMDN Terms

TermDefinition
Receiver-in-canal air-conduction hearing aidA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+4544355600widex@widex.com

Regulatory Flags

DUNS number
309843613
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05714880189377WidexALLURE ARRD1 440210233412024-10-29
05714880209006WidexALLURE ARRD1210289902024-10-29
05714880209013WidexALLURE ARRD1210289952024-10-29
05714880209020WidexALLURE ARRD1210290072024-10-29
05714880209051WidexALLURE ARRD1210289862024-10-29
05714880209068WidexALLURE ARRD1210289822024-10-29
05714880209075WidexALLURE ARRD1210290152024-10-29
05714880209297WidexALLURE ARRD1210290032024-10-29
05714880209303WidexALLURE ARRD1210289992024-10-29
05714880209310WidexALLURE ARRD1 110210289892024-10-29
05714880209327WidexALLURE ARRD1210289782024-10-29
05714880209334WidexALLURE ARRD1 110210290102024-10-29
05714880209341WidexALLURE ARRD1 110210289942024-10-29
05714880209358WidexALLURE ARRD1 110210290062024-10-29
05714880209365WidexALLURE ARRD1 110210289852024-10-29
05714880209372WidexALLURE ARRD1 110210289812024-10-29
05714880209389WidexALLURE ARRD1 110210290142024-10-29

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