FDA.report

Unitron

Primary DI
00698764530613
Brand
Unitron
Company
Unitron Hearing Ltd
Model
063-5703-01
Catalog number
063-5703-01
Device description
Vista 400 312 Wireless Directional
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

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
00698764530613PrimaryGS10

GMDN Terms

TermDefinition
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 typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 519 895 0100Quality@unitron.com

Regulatory Flags

DUNS number
201252087
Device count
1
DM exempt
true
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
07630034362732UNITRON063-6001-01063-6001-012018-02-28
07630034362749UNITRON063-6002-01063-6002-012018-02-28
07630034362756UNITRON063-6003-01063-6003-012018-02-28
07630034362763UNITRON063-6004-01063-6004-012018-02-28
07630034362770UNITRON063-6005-01063-6005-012018-02-28
07630034362787UNITRON063-6006-01063-6006-012018-02-28
07630034362794UNITRON063-6007-01063-6007-012018-02-28
07630034362824UNITRON063-6008-01063-6008-012018-02-28
07630034362831UNITRON063-6009-01063-6009-012018-02-28
07630034362848UNITRON063-6010-01063-6010-012018-02-28
07630034362855UNITRON063-6011-01063-6011-012018-02-28
07630034362886UNITRON063-6012-01063-6012-012018-02-28
07630034362893UNITRON063-6013-01063-6013-012018-02-28
07630034362947UNITRON063-6014-01063-6014-012018-02-28
07630034362961UNITRON063-6015-01063-6015-012018-02-28
07630034362978UNITRON063-6016-01063-6016-012018-02-28
07630034362985UNITRON063-6017-01063-6017-012018-02-28
07630034362992UNITRON063-6018-01063-6018-012018-02-28
07630034363005UNITRON063-6019-01063-6019-012018-02-28
07630034363029UNITRON063-6020-01063-6020-012018-02-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613389755763Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389755770Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389759112Phonak Audéo E90-Sphere Sonova AGOSM2026-03-17
07613389759129Phonak Audéo E70-Sphere Sonova AGOSM2026-03-17
07613389759136Phonak Audéo E50-Sphere Sonova AGOSM2026-03-17
07613389759150Phonak Audéo E-R Trial Sonova AGOSM2026-03-17
07613389759174Phonak Audéo ESphereTrial Sonova AGOSM2026-03-17
07613389761917Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761924Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761931Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761948Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761955Phonak Audéo E30-RSonova AGOSM2026-03-17
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
07613389762044Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762051Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762068Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762075Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762082Phonak Audéo E50-RSonova AGOSM2026-03-17
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