FDA.reportPublic FDA data

EZbra® Breast Dressing

Primary DI
07290017224053
Brand
EZbra® Breast Dressing
Company
EZBRA ADVANCED WOUND CARE LTD
Model
L
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.
Published
2020-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
07290017224053PackageGS110In Commercial Distribution
07290017224084PackageGS16In Commercial Distribution
07290017224114PackageGS15In Commercial Distribution
07290017224022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017224053072900172240537290017224053
07290017224084072900172240847290017224084
07290017224114072900172241147290017224114
07290017224022072900172240227290017224022

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600517193
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017224169EZbra® Breast DressingXS2024-02-19
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
07290017224138 EZbra® Breast DressingXS2020-08-20

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Primary DI, Brand, Company table
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M68931150030TQ™ RAMSafeguard US Operating, LLCMHW2025-01-29
10884450828745SAFEGUARD FOCUS™Merit Medical Systems, Inc.MHW2025-01-01
10193489084658MEDLINEMEDLINE INDUSTRIES, INC.MHW2024-09-13
00810041983572ViveVIVE HEALTH LLCMHW2024-06-07
00810041983589ViveVIVE HEALTH LLCMHW2024-06-07
00810041983596ViveVIVE HEALTH LLCMHW2024-06-07
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00810041983619ViveVIVE HEALTH LLCMHW2024-06-07
00810041982087ViveVIVE HEALTH LLCMHW2024-06-05
00840117327825"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Green"Dynarex CorporationMHW2023-12-20
00840117327849"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Light Blue"Dynarex CorporationMHW2023-12-20
00840117327863"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yds Purple "Dynarex CorporationMHW2023-12-20
00840117327887"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Pink"Dynarex CorporationMHW2023-12-20
00840117327900"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Red"Dynarex CorporationMHW2023-12-20
00840117327924"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Green"Dynarex CorporationMHW2023-12-20
00840117327726"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Green"Dynarex CorporationMHW2023-12-17
00840117327740"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Blue"Dynarex CorporationMHW2023-12-17
00840117327764"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Purple "Dynarex CorporationMHW2023-12-17
00840117327788"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Pink"Dynarex CorporationMHW2023-12-17
00840117327801"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Red "Dynarex CorporationMHW2023-12-17
10811331010173Comfort BandTz Medical, Inc.MHW2023-10-20
10811331010180Comfort BandTz Medical, Inc.MHW2023-10-20
00810113571249ViveVIVE HEALTH LLCMHW2023-08-07
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00810113571959ViveVIVE HEALTH LLCMHW2023-08-07
00810113571966ViveVIVE HEALTH LLCMHW2023-08-07
00810113571973ViveVIVE HEALTH LLCMHW2023-08-07