FDA.reportPublic FDA data

TruTone Plus® Electrolarynx

Primary DI
00813124010738
Brand
TruTone Plus® Electrolarynx
Company
GRIFFIN LABORATORIES
Model
K120
Device description
TruTone Plus® Electrolarynx version 2
Published
2020-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ESELarynx, Artificial (Battery-Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESELarynx, Artificial (Battery-Powered)Ear, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813124010738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813124010738008131240107388131240107380813124010738

GMDN Terms#

Term, Definition table
TermDefinition
Transcervical artificial larynxA battery-powered, speech-assistive device designed to be used by a person who has had their larynx removed (laryngectomy) to assist them in the reproduction of sounds similar to those produced by the vocal cords in normal speech. It is an externally-applied electromechanical device (also known as a neck-type artificial larynx) with a plastic or metal probe that generates a sound (i.e., tone); when the probe is held against the tissues of the neck (or cheek) the tone is transmitted to the mouth through the oropharynx. The appropriate movement of the lips, tongue, teeth, and jaw converts the tone into meaningful speech (i.e., modulates the tone).

Regulatory Flags#

DUNS number
016865375
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813124010981TruTone Plus® Electrolarynx74442021-02-05
00813124010974TruTone Plus® ElectrolarynxKD1202020-08-24
00813124010868TeliTalk™ ElectrolarynxK5200BT-FTRI2020-03-17
00813124010875TeliTalk™ ElectrolarynxK5200LL-FTRI2020-03-17
00813124010004TruTone® ElectrolarynxK1522019-10-23
00813124010035SolaTone® ElectrolarynxK2062019-10-23
00813124010097TruTone® ElectrolarynxKD1362019-10-23
00813124010103SolaTone Plus™ ElectrolarynxKD3552019-10-23
00813124010110SolaTone Lite® ElectrolarynxK3502019-10-23
00813124010127SolaTone Plus™ ElectrolarynxK3552019-10-23
00813124010134TruTone Plus® ElectrolarynxK1202019-10-23
00813124010141TruTone EMOTE® ElectrolarynxK10002019-10-23
00813124010158TruTone EMOTE® Electrolarynx74392019-10-23
00813124010165SolaTone Plus™ ElectrolarynxK220-BRAZIL2019-10-23
00813124010172SolaTone Plus™ Electrolarynx74382019-10-23
00813124010189TruTone EMOTE® ElectrolarynxK1000-CAN2019-10-23
00813124010196TruTone EMOTE® ElectrolarynxK13002019-10-23
00813124010202TruTone Plus® ElectrolarynxK360-22019-10-23
00813124010219TruTone Plus® ElectrolarynxKD1202019-10-23
00813124010226TruTone® ElectrolarynxK1502019-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850057368014Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368021Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368038Blom-SingerEnt Solutions LLCESE2023-12-18
10850057368007Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368011Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368028Blom-SingerEnt Solutions LLCESE2023-12-18
20850057368035Blom-SingerEnt Solutions LLCESE2023-12-18
00860009460508RometFountain Head Marketing Inc.ESE2023-11-15
00860009460515RometFountain Head Marketing Inc.ESE2023-11-15
00860009460522RometFountain Head Marketing Inc.ESE2023-11-15
00860009460539RometFountain Head Marketing Inc.ESE2023-11-15
00860009460546RometFountain Head Marketing Inc.ESE2023-11-15
00860009460591Blom-SingerFountain Head Marketing Inc.ESE2023-11-15
07331791015571Provox TruTone PlusAtos Medical ABESE2022-07-08
07331791015823Provox SolaTone PlusAtos Medical ABESE2022-07-08
07331791015830Provox TruTone EmoteAtos Medical ABESE2022-07-08
04040823006502SERVOX digital XLServona GmbHESE2021-02-18
00813124010981TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2021-02-05
00813124010974TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2020-08-24
00813124010868TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESESE2020-03-17
00813124010875TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESESE2020-03-17
00813124010004TruTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010035SolaTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010097TruTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010103SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010110SolaTone Lite® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010127SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010134TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010141TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010158TruTone EMOTE® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23