Duns Number:001061233
Device Description: Dale Post Surgical Bra, XXX-Large, fits E-I, 54"-60", 1 per box.
Catalog Number
706
Brand Name
Dale Post Surgical Bra
Version/Model Number
706
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
HEF
Product Code Name
Binder, Breast
Public Device Record Key
a85f28a4-ff16-4e22-b5c3-5b485f34191e
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
August 27, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 74 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |