FDA.reportPublic FDA data

UNITRON

Primary DI
07630034315288
Brand
UNITRON
Company
Unitron Hearing Division
Model
050-5772-S5
Catalog number
050-5772-S5
Device description
T Moxi Fit 700 (pewter shine)
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

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
07630034315288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630034315288076300343152887630034315288

GMDN Terms#

Term, Definition table
TermDefinition
Receiver-in-canal 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 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05714880292145WidexWidex A/SOSM2026-05-22
05714880292152WidexWidex A/SOSM2026-05-22
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05714880292190WidexWidex A/SOSM2026-05-22
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05714880292220WidexWidex A/SOSM2026-05-22
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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