FDA UDI
In Commercial Distribution
🇺🇸 United States
Massage Form® Attach
DI: 00812027017677
·
Model: 10475-08-BH
·
AMERICAN BREAST CARE, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Massage Form® Attach
- Primary DI
- 00812027017677
- Version / Model
- 10475-08-BH
- Company Name
- AMERICAN BREAST CARE, L.P.
- Labeler DUNS
- 132124061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-15
- Public Version
- 2
- Public Version Date
- 2021-07-22
- Public Version Status
- Update
- Public Device Record Key
- 64aed5c5-b4db-4629-9739-96240b910d7b
Device 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 8 Blush Color
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCZ | Prosthesis, Breast, External, Used With Adhesive | General, Plastic Surgery | 878.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35676 | External breast prosthesis | An external device intended to replace the female breast typically after a mastectomy. It is made of various materials to simulate the appearance and texture of a breast and is typically fitted into a brassiere. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812027017677 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 595 | Milliliter |