FDA.reportPublic FDA data

Unitron

Primary DI
07613389483468
Brand
Unitron
Company
Unitron Hearing Division
Model
063-6286-01
Catalog number
063-6286-01
Device description
Au3 350 W 312 Dir
Published
2021-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613389483468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389483468076133894834687613389483468

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-the-earA 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) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 519 895 0100quality@unitron.com

Regulatory Flags#

DUNS number
243202080
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613389465013Unitron088-5013088-50132021-04-24
07613389483888Unitron058-5259058-52592021-04-24
07613389483895Unitron058-5260058-52602021-04-24
07613389303285Unitron058-5235058-52352020-12-04
07613389303292Unitron058-5236058-52362020-12-04
07613389444391Unitron088-5012088-50122020-12-04
07613389075823UNITRON088-5001088-50012019-01-16
07613389221572UNITRON058-5228058-52282018-12-10
07613389221589UNITRON058-5229058-52292018-12-10
07613389468601Unitron050-6441-P6050-6441-P62021-10-18
07613389468687Unitron050-6436-P6050-6436-P62021-10-18
07613389468694Unitron050-6437-P6050-6437-P62021-10-18
07613389468700Unitron050-6438-P6050-6438-P62021-10-18
07613389469516Unitron050-6439-P6050-6439-P62021-10-18
07613389469523Unitron050-6436-P2050-6436-P22021-10-18
07613389469530Unitron050-6436-P4050-6436-P42021-10-18
07613389469547Unitron050-6436-P7050-6436-P72021-10-18
07613389469554Unitron050-6436-P8050-6436-P82021-10-18
07613389469561Unitron050-6436-R8050-6436-R82021-10-18
07613389469578Unitron050-6437-P2050-6437-P22021-10-18

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