TONE-A-MATIC

GUDID 06278437251454

Conductive Gel

Tone-A-Matic International Inc

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 06278437251454
• NIH Device Record Key: cbed8ac5-9cae-4a0a-813d-fbef2f7ac1c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TONE-A-MATIC
• Version Model Number: TAMEXX PAD PROLONGER GEL
• Company DUNS: 249661943
• Company Name: Tone-A-Matic International Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	06278437251454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221724

FDA Product Code

• GYB: Media, Electroconductive

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: 2023-02-27
• Device Publish Date: 2023-02-19

On-Brand Devices [TONE-A-MATIC]

• 06278437251454: Conductive Gel
• 06278437251140: Garment Electrodes
• 06278437251072: Garment Electrodes