SERVOX digital XL

GUDID 04040823006502

The SERVOX® digital XL speech aid offers patients, who have lost their voice due to injury, illness or surgical removal of the larynx, the opportunity to quickly regain the ability to communicate. The SERVOX® digital XL can also be used by patients who are temporarily voiceless due to a tracheotomy, who have to protect their vocal folds due to illness or who are connected to a respirator.

Servona GmbH

Transcervical artificial larynx

• Primary Device ID: 04040823006502
• NIH Device Record Key: 58f97477-28df-4acb-a8a4-d696f4388b89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SERVOX digital XL
• Version Model Number: 37575
• Company DUNS: 329895200
• Company Name: Servona GmbH
• Device Count: 1
• DM Exempt: true
• 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	04040823006502 [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: 2021-02-26
• Device Publish Date: 2021-02-18