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AVA Voice 90 Day Kit

FDA UDI

Class II (US FDA UDI)

by Laronix Pty Ltd

Identity

Trade Name
AVA Voice 90 Day Kit FDA UDI
Generic Name
Transcervical artificial larynx FDA UDI
Model / Reference
1.0 FDA UDI

Identifiers

Primary DI / UDI-DI
00860013939007 FDA UDI
FDA Product Code
MCK FDA UDI
GMDN Term
Transcervical artificial larynx FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Transcervical artificial larynx

AVA Voice 90 Day Kit by Laronix Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcervical artificial larynx.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Laronix Pty Ltd

Sources (1)

  • FDA UDI c292e489-b5f3-4432-952e-7d43ce9b87d7 32 fields · synced May 30, 2026