Amoena

Basic Information

• Brand Name: Amoena
• Primary DI: 04026275555843
• Version / Model: 304 Custom +++
• Catalog Number: 304
• Company Name: AMOENA Medizin-Orthopädie-Technik GmbH
• Labeler DUNS: 312770613
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-17
• Public Version: 1
• Public Version Date: 2023-08-25
• Public Version Status: New
• Public Device Record Key: 29e80d66-3e13-4725-8d95-8439477ee7a7

Device Description

The Amoena Custom Breast Form is individually designed and manufactured according the individual needs of each patient.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
35676	External breast prosthesis	An external device intended to replace the female breast typically after a mastectomy. It is made of various materials to simulate the appearance and texture of a breast and is typically fitted into a brassiere.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04026275555843	GS1