Biosonic

GUDID 00860558000422

Microcurrent Facial Sculpting

BIOSONIC TECHNOLOGIES LLC

Transcutaneous electrical stimulation probe

• Primary Device ID: 00860558000422
• NIH Device Record Key: 882240b3-3605-429f-8c32-93db31b4e527
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biosonic
• Version Model Number: Facial Sculpting
• Company DUNS: 080676748
• Company Name: BIOSONIC TECHNOLOGIES LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 954-535-5358
• Email: biosonict@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860558000422 [Primary]
GS1	10605580000425 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130065

FDA Product Code

• NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-08-21
• Device Publish Date: 2017-07-01