SolaTone Plus™ Electrolarynx

GUDID 00813124010165

GRIFFIN LABORATORIES

Transcervical artificial larynx

• Primary Device ID: 00813124010165
• NIH Device Record Key: 4c0f8e66-14ef-45f5-8317-af5a446f5e4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SolaTone Plus™ Electrolarynx
• Version Model Number: K220-BRAZIL
• 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	00813124010165 [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 [SolaTone Plus™ Electrolarynx]

• 00813124010301: K355-CAN
• 00813124010295: K355-1
• 00813124010172: 7438
• 00813124010165: K220-BRAZIL
• 00813124010127: K355
• 00813124010103: KD355