FDA.reportPublic FDA data

Unitron

Primary DI
00698764496957
Brand
Unitron
Company
Unitron Hearing Ltd
Model
076-5020
Catalog number
076-5020
Device description
Generic Remote RCV1
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
00698764496957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00698764496957006987644969576987644969570698764496957

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid enhanced audio device, telecommunication/multimediaA battery-powered device designed to provide high-definition digital wireless audio transmission from an external telecommunication audio source [e.g., television (TV), radio/stereo equipment, mobile phone (cell phone)] to a hearing aid, to enhance the sound quality received by the wearer of the hearing aid. It is typically a hand-held electronic unit, portable or placed in the home, intended to provide features such as artefact-free, echo-free, real-time audio transmission in and sometimes to remotely manage selected features in the hearing aid or external audio source for improved sound quality.

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