FDA.report

Provox TruTone

Primary DI
07331791015571
Brand
Provox TruTone
Company
Atos Medical AB
Model
Plus
Catalog number
7444
Device description
An electrolarynx is a battery-powered artificial larynx that is externally applied on undamaged skin and intended for use in the absence of the larynx or the inability to use the larynx to produce sound.
Published
2022-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ESELarynx, Artificial (Battery-Powered)

Product Code Classifications

CodeDeviceSpecialtyClass
ESELarynx, Artificial (Battery-Powered)Ear, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07331791015571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07331791015571073317910155717331791015571

GMDN Terms

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).

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity45 Percent (%) Relative Humidity
Handling Environment Temperature-4 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight.
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.
Storage Environment Humidity0 Percent (%) Relative Humidity45 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Temperature-4 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags

DUNS number
355470923
Device count
1
DM exempt
false
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

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07331791015830Provox TruToneAtos Medical ABESE2022-07-08
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00813124010875TeliTalk™ ElectrolarynxGRIFFIN LABORATORIESESE2020-03-17
00813124010004TruTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
00813124010035SolaTone® ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
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00813124010127SolaTone Plus™ ElectrolarynxGRIFFIN LABORATORIESESE2019-10-23
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