FDA.reportPublic FDA data

Unitron

Primary DI
00698764508957
Brand
Unitron
Company
Unitron Hearing Ltd
Model
050-5616-35
Catalog number
050-5616-35
Device description
Quantum2 16 HP (taupe)
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

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
00698764508957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00698764508957006987645089576987645089570698764508957

GMDN Terms#

Term, Definition table
TermDefinition
Behind-the-ear 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 microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880292077WidexWidex A/SOSM2026-05-22
05714880292084WidexWidex A/SOSM2026-05-22
05714880292091WidexWidex A/SOSM2026-05-22
05714880292107WidexWidex A/SOSM2026-05-22
05714880292114WidexWidex A/SOSM2026-05-22
05714880292121WidexWidex A/SOSM2026-05-22
05714880292138WidexWidex A/SOSM2026-05-22
05714880292145WidexWidex A/SOSM2026-05-22
05714880292152WidexWidex A/SOSM2026-05-22
05714880292169WidexWidex A/SOSM2026-05-22
05714880292176WidexWidex A/SOSM2026-05-22
05714880292183WidexWidex A/SOSM2026-05-22
05714880292190WidexWidex A/SOSM2026-05-22
05714880292206WidexWidex A/SOSM2026-05-22
05714880292213WidexWidex A/SOSM2026-05-22
05714880292220WidexWidex A/SOSM2026-05-22
05714880292237WidexWidex A/SOSM2026-05-22
05714880292244WidexWidex A/SOSM2026-05-22
05714880292251WidexWidex A/SOSM2026-05-22
05714880292268WidexWidex A/SOSM2026-05-22
05714880292275WidexWidex A/SOSM2026-05-22
05714880292282WidexWidex A/SOSM2026-05-22
05714880292299WidexWidex A/SOSM2026-05-22
05714880292305WidexWidex A/SOSM2026-05-22
05714880292312WidexWidex A/SOSM2026-05-22
05714880292329WidexWidex A/SOSM2026-05-22
05714880292336WidexWidex A/SOSM2026-05-22
05714880292343WidexWidex A/SOSM2026-05-22
05714880292350WidexWidex A/SOSM2026-05-22
05714880292367WidexWidex A/SOSM2026-05-22