Identity
- Trade Name
- EZbra® Breast Dressing FDA UDI
- Generic Name
- Breast binder, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- XS FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017224121 FDA UDI
- FDA Product Code
- MHW FDA UDI
- GMDN Term
- Breast binder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breast binder, single-use
EZbra® Breast Dressing by Ezbra Advanced Wound Care Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ezbra Advanced Wound Care Ltd
Sources (1)
- FDA UDI c54625ab-7ba2-48e0-9e65-43c18d1f635c 33 fields · synced May 30, 2026