FDA.report

Unitron

Primary DI
07613389386929
Brand
Unitron
Company
Unitron Hearing Division
Model
075-5846-10
Catalog number
075-5846-10
Device description
Unitron Charger Moxi R no power supply
Published
2020-04-02
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
07613389386929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613389386929076133893869297613389386929

GMDN Terms

TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

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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07613389762105Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762143Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762150Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762167Phonak Audéo E70-R Sonova AGOSM2026-03-17