TruTone Plus® Electrolarynx

GUDID 00813124010202

GRIFFIN LABORATORIES

Transcervical artificial larynx

• Primary Device ID: 00813124010202
• NIH Device Record Key: c8c1257e-5c36-4f39-8d5a-2c823adf12ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruTone Plus® Electrolarynx
• Version Model Number: K360-2
• 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	00813124010202 [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

On-Brand Devices [TruTone Plus® Electrolarynx]

• 00813124010363: K121
• 00813124010219: KD120
• 00813124010202: K360-2
• 00813124010134: K120
• 00813124010981: TruTone Plus® Electrolarynx version 2