FDA.report

Amoena

Primary DI
04026275502199
Brand
Amoena
Company
AMOENA Medizin-Orthopädie-Technik GmbH
Model
386T Contact 3 E, TW 04 R
Catalog number
386
Device description
Breast Forms
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KCZProsthesis, Breast, External, Used With Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KCZProsthesis, Breast, External, Used With AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026275502199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026275502199040262755021994026275502199

GMDN Terms

TermDefinition
External breast prosthesisAn 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
312770613
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04026275615639Amoena334 Adapt Air Contact Light 2SN 013342025-01-01
04026275615646Amoena334 Adapt Air Contact Light 2SN 023342025-01-01
04026275615653Amoena334 Adapt Air Contact Light 2SN 033342025-01-01
04026275615660Amoena334 Adapt Air Contact Light 2SN 043342025-01-01
04026275615677Amoena334 Adapt Air Contact Light 2SN 053342025-01-01
04026275615684Amoena334 Adapt Air Contact Light 2SN 063342025-01-01
04026275615691Amoena334 Adapt Air Contact Light 2SN 073342025-01-01
04026275615707Amoena334 Adapt Air Contact Light 2SN 083342025-01-01
04026275615714Amoena334 Adapt Air Contact Light 2SN 093342025-01-01
04026275615721Amoena334 Adapt Air Contact Light 2SN 103342025-01-01
04026275615738Amoena334 Adapt Air Contact Light 2SN 113342025-01-01
04026275615745Amoena334 Adapt Air Contact Light 2SN 123342025-01-01
04026275616490Amoena382E Contact 3S EB, 013822024-10-17
04026275616506Amoena382E Contact 3S EB, 023822024-10-17
04026275616513Amoena382E Contact 3S EB, 033822024-10-17
04026275616520Amoena382E Contact 3S EB, 043822024-10-17
04026275616537Amoena382E Contact 3S EB, 053822024-10-17
04026275616544Amoena382E Contact 3S EB, 063822024-10-17
04026275616551Amoena382E Contact 3S EB, 073822024-10-17
04026275616568Amoena382E Contact 3S EB, 083822024-10-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04026275615639AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615646AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615653AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615660AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615677AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615684AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615691AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615707AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615714AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615721AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615738AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275615745AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
04026275616490AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275616506AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275616513AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275616520AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275616537AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275616544AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275616551AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275616568AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275616575AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275616582AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275618012AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275618029AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275618036AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275618043AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275618098AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275618104AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275618111AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17
04026275618128AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2024-10-17