Amoena

Basic Information

• Brand Name: Amoena
• Primary DI: 04026275620473
• Version / Model: 135 Nipple Set ebony medium
• Catalog Number: 135
• Company Name: AMOENA Medizin-Orthopädie-Technik GmbH
• Labeler DUNS: 312770613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-10-09
• Public Version: 2
• Public Version Date: 2025-12-25
• Public Version Status: Update
• Public Device Record Key: e1e254f9-b5a4-47ce-b176-7e9c0057f7c0

Device Description

Nipple Set, accessories for breast prostheses

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
47336	Nipple prosthesis, external	An artificial replacement for a female breast nipple that is applied directly onto the remaining chest wall tissue, or to an external breast prosthesis, typically following a mastectomy. It is typically made of rubber-like silicone material with an adhesive backing for attachment and is an off-the-shelf device offered in different colours and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	40262756204738	GS1
Primary	04026275620473	GS1