Romet

Primary DI
00860009460522
Brand
Romet
Company
Fountain Head Marketing Inc.
Model
R310
Device description
After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the consequent removal of the vocal cords, one is no longer able to speak. This condition is due to the absence of vibrations which were previously produced by the vocal cords. To overcome this challenge, there is no solution other than to artificially produce these vibrations.The ROMET Electronic Larynx or Electrolarynx, produces such vibrations and permits the user to emit clear and very comprehensible vocal sounds.The Romet Model R310 Electrolarynx Includes:2 Year WarrantyDelrin Barrel with Exclusive, New Soft-Grip Barrel w/Anti-Roll FeatureLarger, Ergonomic On/Off ButtonExternal Pitch and Volume ControlsTwo-9V Lithium Batteries w/Smart ChargerLanyard(Important reminder - See a Speech Language Pathologist for help learning where to best use the device on your neck)
Published
2023-11-15
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
00860009460522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009460522008600094605228600094605220860009460522

GMDN Terms#

Term, Definition table
TermDefinition
Voice amplification systemAn assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830442310
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009460508RometR1202023-11-15
00860009460515RometR2102023-11-15
00860009460539RometR7002023-11-15
00860009460546RometR6002023-11-15
00860009460591Blom-SingerEL 20002023-11-15

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
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
00813124010738TruTone Plus® ElectrolarynxGRIFFIN LABORATORIESESE2020-08-24
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