FDA.report

Unitron

Primary DI
07613389274646
Brand
Unitron
Company
Unitron Hearing Division
Model
050-6035-P8
Catalog number
050-6035-P8
Device description
D Moxi Fit FLEX:SELECT (charcoal)
Published
2019-04-12
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
07613389274646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613389274646076133892746467613389274646

GMDN Terms

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

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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