EZCOVER® Gel-Free

Basic Information

• Brand Name: EZCOVER® Gel-Free
• Primary DI: 05407006210962
• Version / Model: PCAG15030-02
• Company Name: MedXPress.Pro
• Labeler DUNS: 371406782
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-28
• Public Version: 1
• Public Version Date: 2024-04-05
• Public Version Status: New
• Public Device Record Key: 21b8bc0d-f26f-429b-8435-70e8bae81eac

Device Description

EZCOVER® Gel-Free 30 cm long

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44713	Body-surface ultrasound imaging transducer cover	A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05407006210979	GS1	Box	50	In Commercial Distribution
Primary	05407006210962	GS1
Package	05407006210986	GS1	Case	300	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K191491	000