EZCOVER® Gel-Free

GUDID 05407006211037

EZCOVER® Gel-Free 122 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: 05407006211037
• NIH Device Record Key: a1584ea8-fcb7-4556-92c5-4ed18bcc3d63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZCOVER® Gel-Free
• Version Model Number: PCAG15122-02
• 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	05407006211020 [Primary]
GS1	05407006211037 [Package]; Contains: 05407006211020; Package: Box [50 Units]; In Commercial Distribution
GS1	05407006211044 [Package]; Contains: 05407006211020; Package: Case [300 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-Free]

• 05407006211068: EZCOVER® Gel-Free 244 cm long
• 05407006211037: EZCOVER® Gel-Free 122 cm long
• 05407006211006: EZCOVER® Gel-Free 61 cm long
• 05407006210979: EZCOVER® Gel-Free 30 cm long