Identity
- Trade Name
- ABC Nipple FDA UDI
- Generic Name
- Nipple prosthesis, external FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 906-M-TW FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811749024826 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.75 Inch FDA UDI
Category: Nipple prosthesis, external
ABC Nipple by American Breast Care Lp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nipple prosthesis, external.
- 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
- my breast — NATURAL BREAST K.K. · Class I
- my breast — NATURAL BREAST K.K. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- American Breast Care Lp
Sources (1)
- FDA UDI 58b0bc28-13a0-4db1-8592-0b3785cee2c5 34 fields · synced Jun 8, 2026