Nipple prosthesis, external 906 ABC Nipple Made of soft silicone with an adhesive back, this nipple prosthesis can be securely attached to a breast form, shaper, or reconstructed breast.…
Nipple prosthesis, external 906 ABC Nipple Made of soft silicone with an adhesive back, this nipple prosthesis can be securely attached to a breast form, shaper, or reconstructed breast. Size Medium Color Tawny
Who Else Makes It
Concentrated in Guangdong (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for ABC Nipple | Listed by | American Breast Care, L.P. |
| FDA product code | KCZ |
| Device type | Prosthesis, Breast, External, Used With Adhesive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3800 |
| Premarket notification | Exempt |
| Record published | 2020-05-15 |
| Record revised | 2025-12-25 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Sizes | Outer diameter 1.5 to 2 in |
| UDI direct marking | Exempt |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.