EZCOVER® Gel-Vision

GUDID 05407006210764

EZCOVER® Gel-Vision 61 cm long

MedXPress.Pro

Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover

• Primary Device ID: 05407006210764
• NIH Device Record Key: 91385659-d094-4c45-9016-22246d7f7a69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZCOVER® Gel-Vision
• Version Model Number: PCG15061-02
• Company DUNS: 371406782
• Company Name: MedXPress.Pro
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05407006210757 [Primary]
GS1	05407006210764 [Package]; Contains: 05407006210757; Package: Box [30 Units]; In Commercial Distribution
GS1	05407006210771 [Package]; Contains: 05407006210757; Package: Case [180 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191491

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-05
• Device Publish Date: 2024-03-28

On-Brand Devices [EZCOVER® Gel-Vision]

• 05407006210825: EZCOVER® Gel-Vision 244 cm long
• 05407006210795: EZCOVER® Gel-Vision 122 cm long
• 05407006210764: EZCOVER® Gel-Vision 61 cm long
• 05407006210733: EZCOVER® Gel-Vision 30 cm long