Medvat

GUDID 00850024089181

Medvat Multi Purpose Ultrasound Gel

Myt Enterprises LLC

Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel 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