AVA Voice Membrane Pack

GUDID 00860013939021

LARONIX PTY LTD

Transcervical artificial larynx
Primary Device ID00860013939021
NIH Device Record Keyc2a03fdf-b525-4229-9b76-6574f0bcb1c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVA Voice Membrane Pack
Version Model Number1.0
Company DUNS745220695
Company NameLARONIX PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860013939021 [Primary]

FDA Product Code

MCKDevice, Voice Amplification

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-23
Device Publish Date2025-05-15

Devices Manufactured by LARONIX PTY LTD

00860013939007 - AVA Voice 90 Day Kit2025-05-23
00860013939014 - AVA Voice Trial Kit2025-05-23
00860013939021 - AVA Voice Membrane Pack2025-05-23
00860013939021 - AVA Voice Membrane Pack2025-05-23

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