FDA.reportPublic FDA data

my breast

Primary DI
04580028446173
Brand
my breast
Company
NATURAL BREAST K.K.
Model
1
Published
2023-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
04580028446173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580028446173045800284461734580028446173

GMDN Terms#

Term, Definition table
TermDefinition
Nipple prosthesis, externalAn artificial replacement for a female breast nipple that is applied to an external breast prosthesis for a mastectomized woman. It is typically made of rubber-like silicone material with an adhesive backing for attachment to the breast prosthesis and is an off-the-shelf device offered in different colours and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
692387886
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580028445909my breast12023-05-31
04580028445961my breast12023-05-31
04580028445978my breast12023-05-31
04580028445985my breast12023-05-31
04580028445992my breast12023-05-31
04580028446005my breast12023-05-31
04580028446012my breast12023-05-31
04580028446029my breast12023-05-31
04580028446036my breast12023-05-31
04580028446043my breast12023-05-31
04580028446067my breast12023-05-31
04580028446074my breast12023-05-31
04580028446081my breast12023-05-31
04580028446098my breast12023-05-31
04580028446104my breast12023-05-31
04580028446111my breast12023-05-31
04580028446128my breast12023-05-31
04580028446135my breast12023-05-31
04580028446142my breast12023-05-31
04580028446159my breast12023-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04026275615646AmoenaAMOENA Medizin-Orthopädie-Technik GmbHKCZ2025-01-01
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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