Duns Number:132124061
Device Description: External Breast Prosthesis with Adhesive11485 Massage Form® Shaper AttachPatented Massage External Breast Prosthesis with Adhesive11485 Massage Form® Shaper AttachPatented Massage Technology- Massages, Hugs, CoolsEnjoy the soothing caress of ABC’s Massage Form® Shaper Attach. Featuring our patented Massage Technology, this shaper cools as it massages to increase comfort, especially for women experiencing symptoms related to lymphedema. ABC’s integrated adhesive prevents shifting for secure comfort that lasts. This shaper conforms to your body’s curves creating a seamless transition and silhouetteSize 12Blush Color
Catalog Number
-
Brand Name
Massage Form® Shaper Attach
Version/Model Number
11485-12-BH
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCZ
Product Code Name
Prosthesis, Breast, External, Used With Adhesive
Public Device Record Key
595eedd3-3dc3-462b-b46d-0d93ee877230
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
May 15, 2020
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 | 30 |