Duns Number:600517193
Device Description: EZbra® breast dressing is a sterile, disposable, elastic binder (or bandage) that is inten 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.
Catalog Number
-
Brand Name
EZbra® Breast Dressing
Version/Model Number
L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
2cf9641a-3343-4370-8960-0fb7e866f5df
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 2020
Package DI Number
07290017224053
Quantity per Package
10
Contains DI Package
07290017224022
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-