FDA UDI
In Commercial Distribution
🇺🇸 United States
EZbra® Breast Dressing
DI: 07290017224008
·
Model: S
·
EZBRA ADVANCED WOUND CARE LTD
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- EZbra® Breast Dressing
- Primary DI
- 07290017224008
- 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
- 2020-08-20
- Public Version
- 1
- Public Version Date
- 2020-08-28
- Public Version Status
- New
- Public Device Record Key
- 25ffdfa5-3f5e-4f2c-8902-42339d7ed6f3
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 07290017224008 | GS1 | ||||
| Package | 07290017224039 | GS1 | 10 | In Commercial Distribution | ||
| Package | 07290017224091 | GS1 | 5 | In Commercial Distribution | ||
| Package | 07290017224060 | GS1 | shipper | 6 | In Commercial Distribution |