AVA Voice 90 Day Kit AVA-VOICE-KIT-2

GUDID 00860013939038

LARONIX PTY LTD

Transcervical artificial larynx

• Primary Device ID: 00860013939038
• NIH Device Record Key: 50be4f0e-4f3e-4afb-9657-a0aee7ea9b4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVA Voice 90 Day Kit
• Version Model Number: 2.0
• Catalog Number: AVA-VOICE-KIT-2
• 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	00860013939038 [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: 2025-11-19
• Device Publish Date: 2025-11-11

On-Brand Devices [AVA Voice 90 Day Kit]

• 00860013939007: 1.0
• 00860013939038: 2.0