Duns Number:067647321
Device Description: The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
Catalog Number
-
Brand Name
Aware Breast Self-Exam Pad
Version/Model Number
1203
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2020
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K991469
Product Code
IYO
Product Code Name
System, Imaging, Pulsed Echo, Ultrasonic
Public Device Record Key
1ca6430e-d524-4f21-b85a-0c085b7c5701
Public Version Date
September 02, 2021
Public Version Number
4
DI Record Publish Date
December 07, 2016
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |