FDA.report

UNITRON

Primary DI
07630034327410
Brand
UNITRON
Company
Unitron Hearing Division
Model
076-5046-T820
Catalog number
076-5046-T820
Device description
uStream generic w/ Univ. Power Supply
Published
2018-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

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
07630034327410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630034327410076300343274107630034327410

GMDN Terms

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

Contacts

PhoneEmail
+1 519 895 0100quality@unitron.com

Regulatory Flags

DUNS number
243202080
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
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
07613389469585Unitron050-6437-P4050-6437-P42021-10-18
07613389469592Unitron050-6437-P7050-6437-P72021-10-18
07613389469608Unitron050-6437-P8050-6437-P82021-10-18
07613389469813Unitron050-6437-R8050-6437-R82021-10-18
07613389469820Unitron050-6438-P2050-6438-P22021-10-18
07613389469837Unitron050-6438-P4050-6438-P42021-10-18
07613389469844Unitron050-6438-P7050-6438-P72021-10-18
07613389469851Unitron050-6438-P8050-6438-P82021-10-18
07613389469868Unitron050-6438-R8050-6438-R82021-10-18

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