FDA.reportPublic FDA data

Unitron TrueFit 5.10

Primary DI
07613389867022
Brand
Unitron TrueFit 5.10
Company
Sonova AG
Model
088-5019-000510
Catalog number
088-5019-000510
Published
2026-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

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
07613389867022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389867022076133898670227613389867022

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).

Contacts#

Phone, Email table
PhoneEmail
+41589280101info@sonova.com

Regulatory Flags#

DUNS number
480662550
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
07613389840599Moxi S9-RX(velvet black)050-6927-P82026-07-26
07613389840605Moxi S9-RX(sand)050-6927-R82026-07-26
07613389842012Moxi S7-RX(amber beige)050-6926-P22026-07-26
07613389842029Moxi S7-RX(chestnut)050-6926-P42026-07-26
07613389842036Moxi S7-RX(silver gray)050-6926-P62026-07-26
07613389842043Moxi S7-RX(graphite gray)050-6926-P72026-07-26
07613389842050Moxi S7-RX(velvet black)050-6926-P82026-07-26
07613389842067Moxi S7-RX(sand)050-6926-R82026-07-26
07613389842074Moxi S9-RX(amber beige)050-6927-P22026-07-26
07613389842081Moxi S9-RX(chestnut)050-6927-P42026-07-26
07613389842098Moxi S9-RX(silver gray)050-6927-P62026-07-26
07613389842104Moxi S9-RX(graphite gray)050-6927-P72026-07-26
07613389842111Moxi S-RX FLEX:TRIAL(silver gray)050-6928-P62026-07-26
07613389843682Relate5.0 Platinum RIC RX(sand)050-6927-R8762026-07-26
07613389843699Relate5.0 RIC RX DEMO(silver gray)050-6928-P6762026-07-26
07613389844627Relate5.0 Gold RIC RX(chestnut)050-6926-P4762026-07-26
07613389844634Relate5.0 Gold RIC RX050-6926-P676050-6926-P6762026-07-26
07613389844641Relate5.0 Gold RIC RX(sand)050-6926-R8762026-07-26
07613389844658Relate5.0 Platinum RIC RX(chestnut)050-6927-P4762026-07-26
07613389844665Relate5.0 Platinum RIC RX(silver gray)050-6927-P6762026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389840599Moxi S9-RXSonova AGOSM2026-07-26
07613389840605Moxi S9-RXSonova AGOSM2026-07-26
07613389842012Moxi S7-RXSonova AGOSM2026-07-26
07613389842029Moxi S7-RXSonova AGOSM2026-07-26
07613389842036Moxi S7-RXSonova AGOSM2026-07-26
07613389842043Moxi S7-RXSonova AGOSM2026-07-26
07613389842050Moxi S7-RXSonova AGOSM2026-07-26
07613389842067Moxi S7-RXSonova AGOSM2026-07-26
07613389842074Moxi S9-RXSonova AGOSM2026-07-26
07613389842081Moxi S9-RXSonova AGOSM2026-07-26
07613389842098Moxi S9-RXSonova AGOSM2026-07-26
07613389842104Moxi S9-RXSonova AGOSM2026-07-26
07613389842111Moxi S-RX FLEX:TRIALSonova AGOSM2026-07-26
07613389843682Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389843699Relate5.0 RIC RX DEMOSonova AGOSM2026-07-26
07613389844627Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844634Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844641Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844658Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389844665Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389844955Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844962Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844979Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844986Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844993Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389845006Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389867039Aura:fit AudioNova 5.10Sonova AGOSM2026-07-26
07613389867046Aura:fit 5.10Sonova AGOSM2026-07-26
07613389867053HANSATON scout 5.10Sonova AGOSM2026-07-26
07613389867060Aura:fit Relate 5.10Sonova AGOSM2026-07-26