Duns Number:132124061
Device Description: External Breast Prosthesis with Adhesive 10475 Massage Form® Attach Patented Massage Techn External Breast Prosthesis with Adhesive 10475 Massage Form® Attach Patented Massage Technology- Massages, Hugs, CoolsEnjoy the cooling comfort and secure wear of the Massage Form ® Attach. ABC’s integrated adhesive keeps this lightweight formsecurely in place for a natural look and comfortable fit. Featuring ABC’s Patented Massage Technology, specialized channelsencourage airflow, helping to reduce heat retention and provide a soothing touch. This prosthesis is especially great for womenexperiencing symptoms associated with Lymphedema.Size 11Blush Color
Catalog Number
-
Brand Name
Massage Form® Attach
Version/Model Number
10475-11-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
9e0700b7-a1bf-4305-bbef-6666d0993aa1
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 |