FDA.reportPublic FDA data

TRIANGLE

Primary DI
08054187380778
Brand
TRIANGLE
Company
INVENTIS SRL
Model
TRIANGLE
Catalog number
11689
Device description
AUDIOMETER.Screening audiometer, capable of performing fast and accurate air and bone conduction threshold examination and screening test.
Published
2020-03-06
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
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054187380778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054187380778080541873807788054187380778

GMDN Terms#

Term, Definition table
TermDefinition
Pure-tone audiometerAn electroacoustic device that generates tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presents them to a patient, typically one ear at a time with headphones, to evaluate hearing. The difference between the patient threshold and the normal (i.e., the hearing loss) is typically recorded on an audiogram chart in decibels. The device may be equipped with a bone vibrator for direct inner-ear stimulation to corroborate hearing loss. A masking tone system is necessary for testing if there is a large difference in hearing between the ears.

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
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23
057117810041673000 Real EarAuditdata A/SEWO2026-01-23
057117810041743000 Real EarAuditdata A/SEWO2026-01-23
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
B43056000011100GoCheckGobiquity, Inc.EWO2025-12-02
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07