FDA UDI
In Commercial Distribution
🇺🇸 United States
Massage Form® Shaper Attach
DI: 00811749021887
·
Model: 11485-04-BH
·
AMERICAN BREAST CARE, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Massage Form® Shaper Attach
- Primary DI
- 00811749021887
- Version / Model
- 11485-04-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
- 4bf186a7-318c-42e6-936b-e99858ea3eff
Device 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 4 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 | 00811749021887 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 120 | Milliliter |