FDA.reportPublic FDA data

VIOLA

Primary DI
08054187380426
Brand
VIOLA
Company
INVENTIS SRL
Model
VIOLA PLUS
Catalog number
10374
Device description
MIDDLE EAR ANALYZER / AUDIOMETER.Viola Plus is a middle ear analyzer / audiometer, capable of performing tympanometry and acoustic reflex tests in sequence and automatically, reflex test decay; pure tone and speech audiometry using air and bone conduction.
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PTOTester, Auditory Impedance, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTOTester, Auditory Impedance, ExemptEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054187380426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054187380426080541873804268054187380426

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometerAn electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39 0498962844sales@inventis.it

Regulatory Flags#

DUNS number
338454995
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054187381232easyTympeasyTymp124672026-04-23
08054187381249easyTymp Docking StationeasyTymp Docking Station124682026-04-23
08054187380815Synapsys VHITSynapsys VHIT Basic107382025-01-08
08054187380822Synapsys VHITSynapsys VHIT Plus107392025-01-08
08054187380983VNGVNG BASIC WIRELESS114632024-10-01
08054187380990VNGVNG BASIC WIRELESS - XPR11463-XPR2024-10-01
08054187381003VNGVNG PLUS WIRELESS114642024-10-01
08054187381010VNGVNG PLUS WIRELESS - XPR 11464-XPR2024-10-01
08054187381027VNGVNG BASIC WIRED106192024-10-01
08054187381034VNGVNG PLUS WIRED106202024-10-01
08054187381041VNGVIDEO-SCOPE WIRELESS114472024-10-01
08054187381058VNGVIDEO-SCOPE WIRELESS - XPR11447-XPR2024-10-01
08054187381065VNGVIDEO-SCOPE WIRED119612024-10-01
08054187381140HARMONICAHARMONICA112052023-12-11
08054187380730DRUMDRUM112392017-08-24
08054187380020BELLBELL PLUS101442016-09-17
08054187380044HARPHARP BASIC101452016-09-17
08054187380051HARPHARP BASIC WITH PRINTER101622016-09-17
08054187380068HARPHARP PLUS101462016-09-17
08054187380075HARPHARP PLUS WITH PRINTER101632016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054187381232easyTympINVENTIS SRLPTO2026-04-23
08054187381249easyTymp Docking StationINVENTIS SRLPTO2026-04-23
00860007953736WavelyDx Ear Tip - Pack of 3Wavely Diagnostics, Inc.PTO2026-04-03
00860007953767WavelyDx Middle Ear Fluid CMD iOS ApplicationWavely Diagnostics, Inc.PTO2026-04-03
00860007953774WavelyDx Ear Tip - Pack of 6Wavely Diagnostics, Inc.PTO2026-04-03
00860007953781WavelyDx Ear Tip - Pack of 2Wavely Diagnostics, Inc.PTO2026-04-03
08054187380761TIMPANI DOCKING STATIONINVENTIS SRLPTO2023-01-04
00860007953705Wavely Ear TipWavely Diagnostics, Inc.PTO2022-08-08
00860007953712WavelyDx Middle Ear Fluid CMD iOS ApplicationWavely Diagnostics, Inc.PTO2022-08-08
08054187380747TIMPANIINVENTIS SRLPTO2019-04-16
08054187380259FLUTEINVENTIS SRLPTO2016-09-17
08054187380266FLUTEINVENTIS SRLPTO2016-09-17
08054187380273FLUTEINVENTIS SRLPTO2016-09-17
08054187380280FLUTEINVENTIS SRLPTO2016-09-17
08054187380440FLUTEINVENTIS SRLPTO2016-09-17
08054187380457FLUTEINVENTIS SRLPTO2016-09-17
08054187380464CLARINETINVENTIS SRLPTO2016-09-17
08054187380471CLARINETINVENTIS SRLPTO2016-09-17
08054187380488CLARINETINVENTIS SRLPTO2016-09-17
08054187380495CLARINETINVENTIS SRLPTO2016-09-17
08054187380402VIOLAINVENTIS SRLPTO2016-09-17
08054187380419VIOLAINVENTIS SRLPTO2016-09-17
08054187380433VIOLAINVENTIS SRLPTO2016-09-17