TruTone Plus® Electrolarynx

GUDID 00813124010981

TruTone Plus® Electrolarynx version 2

GRIFFIN LABORATORIES

Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx Transcervical artificial larynx

• Primary Device ID: 00813124010981
• NIH Device Record Key: 2c6d20c3-6c81-4b66-97d6-a1e598c94bfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruTone Plus® Electrolarynx
• Version Model Number: 7444
• 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	00813124010981 [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: 2021-02-15
• Device Publish Date: 2021-02-05

On-Brand Devices [TruTone Plus® Electrolarynx]

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