Medvat

GUDID 00850024089181

Medvat Multi Purpose Ultrasound Gel

Myt Enterprises LLC

Skin topical coupling gel

• Primary Device ID: 00850024089181
• NIH Device Record Key: 997b2449-53f6-4e65-91cb-0c7813bdc031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medvat
• Version Model Number: MED-USG-CLEAR-5L-N-A
• Company DUNS: 058952033
• Company Name: Myt Enterprises 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850024089174 [Primary]
GS1	00850024089181 [Package]; Contains: 00850024089174; Package: case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012522

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2024-06-14
• Device Publish Date: 2024-06-06

On-Brand Devices [Medvat]

• 00850024089822: Medvat Ultrasonic Gel with Aloe Vera 8.5oz 2-Pack
• 00850024089549: Medvat Ultrasonic Gel with Aloe Vera 5-Liter 4-Pack
• 00850024089211: Medvat Ultrasonic Gel with Aloe Vera 20g 100-Pack
• 00850024089181: Medvat Multi Purpose Ultrasound Gel