Identity
- Trade Name
- Massage Form® Shaper Attach FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Device Name
- External Breast Prosthesis with Adhesive 11485 Massage Form® Shaper Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy 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 silhouette Size 7 Blush Color FDA UDI
- Model / Reference
- 11485-07-BH FDA UDI
- Description
- External Breast Prosthesis with Adhesive 11485 Massage Form® Shaper Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy 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 silhouette Size 7 Blush Color FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811749021917 FDA UDI
- FDA Product Code
- KCZ FDA UDI
- GMDN Term
- External breast prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 200 Milliliter FDA UDI
Category: External breast prosthesis
Massage Form® Shaper Attach by American Breast Care Lp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- American Breast Care Lp
Sources (1)
- FDA UDI 69b8e8ab-6239-4824-8fd8-139f1db3297f 34 fields · synced May 30, 2026