FDA.reportPublic FDA data

EZbra® Breast Dressing

Primary DI
07290017224169
Brand
EZbra® Breast Dressing
Company
EZBRA ADVANCED WOUND CARE LTD
Model
XS
Device description
EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is intended to support and compress breasts andabsorb 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.
Published
2024-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017224213PackageGS130In Commercial Distribution
07290017224169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017224213072900172242137290017224213
07290017224169072900172241697290017224169

GMDN Terms#

Term, Definition table
TermDefinition
Breast binder, single-useA 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.

Regulatory Flags#

DUNS number
600517193
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017224176EZbra® Breast DressingS2024-02-19
07290017224183EZbra® Breast DressingM2024-02-19
07290017224190EZbra® Breast DressingL2024-02-19
07290017224213EZbra® Breast DressingXS2024-02-19
07290017224220EZbra® Breast DressingS2024-02-19
07290017224237EZbra® Breast DressingM2024-02-19
07290017224244EZbra® Breast DressingL2024-02-19
07290017224015 EZbra® Breast DressingM2020-08-20
07290017224022 EZbra® Breast DressingL2020-08-20
07290017224121 EZbra® Breast DressingXS2020-08-20
07290017224008 EZbra® Breast DressingS2020-08-20
07290017224046 EZbra® Breast DressingM2020-08-20
07290017224053 EZbra® Breast DressingL2020-08-20
07290017224138 EZbra® Breast DressingXS2020-08-20

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