AVA Voice Membrane Pack

GUDID 00860013939021

LARONIX PTY LTD

Transcervical artificial larynx

• Primary Device ID: 00860013939021
• NIH Device Record Key: c2a03fdf-b525-4229-9b76-6574f0bcb1c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVA Voice Membrane Pack
• Version Model Number: 1.0
• Company DUNS: 745220695
• Company Name: LARONIX PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013939021 [Primary]

FDA Product Code

• MCK: Device, Voice Amplification

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-23
• Device Publish Date: 2025-05-15

Devices Manufactured by LARONIX PTY LTD

• 00860013939038 - AVA Voice 90 Day Kit: 2025-11-19
• 00860013939045 - AVA Voice Trial Kit: 2025-11-19
• 00860013939007 - AVA Voice 90 Day Kit: 2025-05-23
• 00860013939014 - AVA Voice Trial Kit: 2025-05-23
• 00860013939021 - AVA Voice Membrane Pack: 2025-05-23
• 00860013939021 - AVA Voice Membrane Pack: 2025-05-23