EZbra® Breast Dressing

Basic Information

• Brand Name: EZbra® Breast Dressing
• Primary DI: 07290017224176
• Version / Model: S
• Company Name: EZBRA ADVANCED WOUND CARE LTD
• Labeler DUNS: 600517193
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-19
• Public Version: 1
• Public Version Date: 2024-02-27
• Public Version Status: New
• Public Device Record Key: bc818997-bf20-4996-b5e3-32819e925c45

Device Description

EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts and absorb fluids following invasive breast procedures such as aesthetic surgery, biopsy, lumpectomy, breast reduction, mastectomy, and reconstruction. The device is intended for single use and should be changed daily or according to doctor’s instructions.

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MHW	Dressing, Compression	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10483	Breast binder, single-use	A fabric wrap intended to be applied to the breast(s) for soft tissue support, typically after surgery; it is not a brassiere (bra). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07290017224220	GS1		30	In Commercial Distribution
Primary	07290017224176	GS1