Identity
- Trade Name
- my breast FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04580028446180 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
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: External breast prosthesisNipple prosthesis, external
my breast by Natural Breast K.k. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nipple prosthesis, external.
- ABC Nipple — AMERICAN BREAST CARE LP · Class I
- ABC Nipple — AMERICAN BREAST CARE LP · Class I
- ABC Nipple — AMERICAN BREAST CARE LP · Class I
- Amoena — AMOENA Medizin-Orthopädie-Technik GmbH · Class I
- ABC Nipple — AMERICAN BREAST CARE LP · Class I
- Amoena — AMOENA Medizin-Orthopädie-Technik GmbH · Class I
- ABC Nipple — AMERICAN BREAST CARE LP · Class I
- Amoena — AMOENA Medizin-Orthopädie-Technik GmbH · Class I
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
- Natural Breast K.k.
Sources (1)
- FDA UDI 465c6d41-a365-491e-be0d-794e6ca5e113 32 fields · synced Jun 8, 2026