FDA.reportPublic FDA data

Amoena

Primary DI
04026275615677
Brand
Amoena
Company
AMOENA Medizin-Orthopädie-Technik GmbH
Model
334 Adapt Air Contact Light 2SN 05
Catalog number
334
Device description
Breast Form
Published
2025-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
KCZProsthesis, Breast, External, Used With Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCZProsthesis, Breast, External, Used With AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026275615677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026275615677040262756156774026275615677

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
312770613
Device count
1
Premarket exempt
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026275620459Amoena135 Nipple Set ebony small1352024-10-09
04026275620466Amoena135 Nipple Set ebony large1352024-10-09
04026275620473Amoena135 Nipple Set ebony medium1352024-10-09
04026275623122Amoena 136 Nipple Set ivory medium1362023-10-09
04026275623139Amoena 136 Nipple Set ivory large1362023-10-09
04026275623146Amoena 137 Nipple Set almond small1372023-10-09
04026275623153Amoena 137 Nipple Set almond meduim1372023-10-09
04026275623160Amoena 137 Nipple Set almond large1372023-10-09
04026275623177Amoena 138 Nipple Set bronze small1382023-10-09
04026275623184Amoena 138 Nipple Set bronze medium1382023-10-09
04026275623191Amoena 138 Nipple Set bronze large1382023-10-09
04026275623207Amoena 139 Nipple Set tawny small1392023-10-09
04026275623214Amoena 139 Nipple Set tawny medium1392023-10-09
04026275623221Amoena 139 Nipple Set tawny large1392023-10-09
04026275623115Amoena 136 Nipple Set ivory small1362023-10-09
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
04026275615684Amoena334 Adapt Air Contact Light 2SN 063342025-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810008657904ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
00810008657911ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
00810008657928ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
00810008657935ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
00810008657942ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
00810008657959ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
00810008657966ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
00810008657973ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
00810008657980ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
00810008657997ABC Diamond AttachAMERICAN BREAST CARE, L.P.KCZ2026-10-09
ESTOI0207Z4300StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2026-09-28
H0005KX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2026-05-08
H0005TX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2026-05-08
ESTOI0206X5200StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-10-08
ESTOI0207X3700StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-10-08
ESTOV0003X2600StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-10-08
ESTOV0008W2650StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-10-08
ESTOI3401K2500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3401K4500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3401T4000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3401X2600StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3401X4500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3401X6000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3401X8000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3401Z4500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3402K2000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3402T3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3402X2600StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
ESTOI3402Z3300StecoTitanmagnetics®steco-System-Technik GmbH & Co KGKCZ2025-05-22
04026275615639AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01