TruTone Plus® Electrolarynx

Basic Information

• Brand Name: TruTone Plus® Electrolarynx
• Primary DI: 00813124010219
• Version / Model: KD120
• Company Name: GRIFFIN LABORATORIES
• Labeler DUNS: 016865375
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-23
• Public Version: 1
• Public Version Date: 2019-10-31
• Public Version Status: New
• Public Device Record Key: baca807a-979d-4027-b79b-dde5841abfc8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ESE	Larynx, Artificial (Battery-Powered)	Ear, Nose, Throat	874.3375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34857	Transcervical artificial larynx	A battery-powered, speech-assistive device designed to be used by a person who has had their larynx removed (laryngectomy) to assist them in the reproduction of sounds similar to those produced by the vocal cords in normal speech. It is an externally-applied electromechanical device (also known as a neck-type artificial larynx) with a plastic or metal probe that generates a sound (i.e., tone); when the probe is held against the tissues of the neck (or cheek) the tone is transmitted to the mouth through the oropharynx. The appropriate movement of the lips, tongue, teeth, and jaw converts the tone into meaningful speech (i.e., modulates the tone).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813124010219	GS1