Liberty® Electrolarynx

GUDID 00813124010318

GRIFFIN LABORATORIES

Transcervical artificial larynx

• Primary Device ID: 00813124010318
• NIH Device Record Key: a90ff850-99dc-48c7-a725-8ad98e914708
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liberty® Electrolarynx
• Version Model Number: K306
• Company DUNS: 016865375
• Company Name: GRIFFIN LABORATORIES
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813124010318 [Primary]

FDA Product Code

• ESE: Larynx, Artificial (Battery-Powered)

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: 2019-10-31
• Device Publish Date: 2019-10-23

Devices Manufactured by GRIFFIN LABORATORIES

• 00813124010981 - TruTone Plus® Electrolarynx: 2021-02-15 TruTone Plus® Electrolarynx version 2
• 00813124010868 - TeliTalk™ Electrolarynx: 2020-03-25
• 00813124010875 - TeliTalk™ Electrolarynx: 2020-03-25
• 00813124010004 - TruTone® Electrolarynx: 2019-10-31
• 00813124010035 - SolaTone® Electrolarynx: 2019-10-31
• 00813124010097 - TruTone® Electrolarynx: 2019-10-31
• 00813124010103 - SolaTone Plus™ Electrolarynx: 2019-10-31
• 00813124010110 - SolaTone Lite® Electrolarynx: 2019-10-31