FDA.reportPublic FDA data

Unitron

Primary DI
07613389453591
Brand
Unitron
Company
Unitron Hearing Division
Model
050-6404-P644
Catalog number
050-6404-P644
Device description
Vista B9-312 (platinum)
Published
2021-04-24
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
07613389453591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389453591076133894535917613389453591

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA 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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296253173GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253203GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253210GN ReSoundGn Hearing A/SOSM2026-09-21
05708296253234GN ReSoundGn Hearing A/SOSM2026-09-21
05708296258031GN ReSoundGn Hearing A/SOSM2026-09-21
05708296357796GN ReSoundGn Hearing A/SOSM2025-08-06
05708296357901GN ReSoundGn Hearing A/SOSM2025-08-06
05708296358144BeltoneGn Hearing A/SOSM2025-08-06
05708296358243BeltoneGn Hearing A/SOSM2025-08-06
05708296362196GN ReSoundGn Hearing A/SOSM2025-03-27
05708296362332GN ReSoundGn Hearing A/SOSM2025-03-27
05708296362431GN ReSoundGn Hearing A/SOSM2025-03-27
05708296362639GN ReSoundGn Hearing A/SOSM2025-03-27
05708296363087BeltoneGn Hearing A/SOSM2025-03-27
05708296364862GN ReSoundGn Hearing A/SOSM2025-03-27
05708296366118GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366514GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366545GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366583GN ReSoundGn Hearing A/SOSM2025-02-05
05708296366750BeltoneGn Hearing A/SOSM2025-02-05
05708296366880BeltoneGn Hearing A/SOSM2025-02-05
05708296366903BeltoneGn Hearing A/SOSM2025-02-05
05708296366972BeltoneGn Hearing A/SOSM2025-02-05
05708296367481BeltoneGn Hearing A/SOSM2025-02-05
05708296355044GN HearingGn Hearing A/SOSM2024-08-09
05708296336173GN HearingGn Hearing A/SOSM2024-05-09
05708296335510GN ReSoundGn Hearing A/SOSM2024-05-08
05708296335527GN ReSoundGn Hearing A/SOSM2024-05-08
05708296335596GN ReSoundGn Hearing A/SOSM2024-05-08
05708296336227GN HearingGn Hearing A/SOSM2024-05-08