AVA Voice Trial Kit

Primary DI
00860013939014
Brand
AVA Voice Trial Kit
Company
LARONIX PTY LTD
Model
1.0
Published
2025-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
MCKDevice, Voice Amplification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCKDevice, Voice AmplificationEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013939014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013939014008600139390148600139390140860013939014

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
745220695
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013939038AVA Voice 90 Day Kit2.0AVA-VOICE-KIT-22025-11-11
00860013939045AVA Voice Trial Kit2.0AVA-TRIAL-KIT-22025-11-11
00860013939007AVA Voice 90 Day Kit1.02025-05-15
00860013939021AVA Voice Membrane Pack1.02025-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013939038AVA Voice 90 Day KitLARONIX PTY LTDMCK2025-11-11
00860013939045AVA Voice Trial KitLARONIX PTY LTDMCK2025-11-11
00860013939007AVA Voice 90 Day KitLARONIX PTY LTDMCK2025-05-15
00860013939021AVA Voice Membrane PackLARONIX PTY LTDMCK2025-05-15