Identity
- Trade Name
- Amoena FDA UDI
- Generic Name
- Nipple prosthesis, external FDA UDI
- Device Name
- Nipple Set, accessories for breast prostheses FDA UDI
- Model / Reference
- 138 Nipple Set bronze large FDA UDI
- Description
- Nipple Set, accessories for breast prostheses FDA UDI
Identifiers
- Catalog Number
- 138 FDA UDI
- Primary DI / UDI-DI
- 04026275623191 FDA UDI
- FDA Product Code
- KCZ FDA UDI
- GMDN Term
- Nipple prosthesis, external 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nipple prosthesis, external
Amoena by AMOENA Medizin-Orthopädie-Technik GmbH — 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
- my breast — NATURAL BREAST K.K. · Class I
- my breast — NATURAL BREAST K.K. · Class I
- my breast — NATURAL BREAST K.K. · Class I
- my breast — NATURAL BREAST K.K. · Class I
- my breast — NATURAL BREAST K.K. · Class I
- ABC Nipple — AMERICAN BREAST CARE LP · Class I
- my breast — NATURAL BREAST K.K. · 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
- AMOENA Medizin-Orthopädie-Technik GmbH
Sources (1)
- FDA UDI 0518bf33-97af-485f-99f3-ead20eda71d9 34 fields · synced May 30, 2026