Identity
- Trade Name
- Massage Form® Attach FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Device Name
- External Breast Prosthesis with Adhesive 10475 Massage Form® Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy the cooling comfort and secure wear of the Massage Form ® Attach. ABC’s integrated adhesive keeps this lightweight form securely in place for a natural look and comfortable fit. Featuring ABC’s Patented Massage Technology, specialized channels encourage airflow, helping to reduce heat retention and provide a soothing touch. This prosthesis is especially great for women experiencing symptoms associated with Lymphedema. Size 6 Blush Color FDA UDI
- Model / Reference
- 10475-06-BH FDA UDI
- Description
- External Breast Prosthesis with Adhesive 10475 Massage Form® Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy the cooling comfort and secure wear of the Massage Form ® Attach. ABC’s integrated adhesive keeps this lightweight form securely in place for a natural look and comfortable fit. Featuring ABC’s Patented Massage Technology, specialized channels encourage airflow, helping to reduce heat retention and provide a soothing touch. This prosthesis is especially great for women experiencing symptoms associated with Lymphedema. Size 6 Blush Color FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812027017653 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 — 410 Milliliter FDA UDI
Category: External breast prosthesis
Massage Form® 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 9420787e-2bcf-4a85-a80c-3711829d45d0 34 fields · synced Jun 1, 2026