EZbra® Breast Dressing

GUDID 07290017224138

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.

EZBRA ADVANCED WOUND CARE LTD

Breast binder, single-use

• Primary Device ID: 07290017224138
• NIH Device Record Key: c54625ab-7ba2-48e0-9e65-43c18d1f635c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZbra® Breast Dressing
• Version Model Number: XS
• Company DUNS: 600517193
• Company Name: EZBRA ADVANCED WOUND CARE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017224121 [Primary]
GS1	07290017224138 [Package]; Contains: 07290017224121; Package: [10 Units]; In Commercial Distribution
GS1	07290017224145 [Package]; Package: shipper [6 Units]; In Commercial Distribution
GS1	07290017224152 [Package]; Contains: 07290017224121; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• MHW: Dressing, Compression

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: 2020-08-28
• Device Publish Date: 2020-08-20

On-Brand Devices [ EZbra® Breast Dressing]

• 07290017224138: EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended t
• 07290017224053: EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended t
• 07290017224046: EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended t
• 07290017224008: EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended t