FDA.report

Widex

Primary DI
05706069722772
Brand
Widex
Company
Widex A/S
Model
CROS-FA
Catalog number
8 931 0100 821
Device description
Widex CROS-FA BTE (Winter silver SWAP ) Volume control
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
05706069722772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05706069722772057060697227725706069722772

GMDN Terms

TermDefinition
Contralateral hearing unitA passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routing of sound (CROS) technology is designed to improve awareness of sounds (e.g., traffic, speech) emanating from all directions. The device typically consists of a microphone contained in a case worn behind-the-ear (BTE) with a connection cable. The cable both transmits the power from, and the signal to, the active hearing aid.

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05714880266825WidexWPP101210448492025-09-26
05714880208993WidexALLURE ARRD1210290112025-03-06
05714880209624WidexALLURE ARRD1 440210289412025-03-06
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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07613389755763Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389755770Phonak Audéo E30-RSonova AGOSM2026-03-17
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07613389759129Phonak Audéo E70-Sphere Sonova AGOSM2026-03-17
07613389759136Phonak Audéo E50-Sphere Sonova AGOSM2026-03-17
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07613389759174Phonak Audéo ESphereTrial Sonova AGOSM2026-03-17
07613389761917Phonak Audéo E30-RSonova AGOSM2026-03-17
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07613389761931Phonak Audéo E30-RSonova AGOSM2026-03-17
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07613389761962Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761979Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761986Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761993Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762006Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762013Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762020Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762037Phonak Audéo E50-RSonova AGOSM2026-03-17
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07613389762068Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762075Phonak Audéo E50-RSonova AGOSM2026-03-17
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07613389762099Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762105Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762143Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762150Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762167Phonak Audéo E70-R Sonova AGOSM2026-03-17