FDA.reportPublic FDA data

ABC Nipple

Primary DI
00811749024796
Brand
ABC Nipple
Company
AMERICAN BREAST CARE, L.P.
Model
906-M-BH
Device description
Nipple prosthesis, external906 ABC NippleMade of soft silicone with an adhesive back, this nipple prosthesis can be securely attached to a breast form, shaper, or reconstructed breast.Size MediumColor Blush
Published
2020-05-15
Public version status
Update
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
00811749024796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811749024796008117490247968117490247960811749024796

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.75Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
132124061
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811749024758ABC Nipple906-S-IV2020-05-15
00811749024765ABC Nipple906-M-IV2020-05-15
00811749024772ABC Nipple906-L-IV2020-05-15
00811749024789ABC Nipple906-S-BH2020-05-15
00811749024802ABC Nipple906-L-BH2020-05-15
00811749024819ABC Nipple906-S-TW2020-05-15
00811749024826ABC Nipple906-M-TW2020-05-15
00811749024833ABC Nipple906-L-TW2020-05-15
00811749021887Massage Form® Shaper Attach11485-04-BH2020-05-15
00811749021894Massage Form® Shaper Attach11485-05-BH2020-05-15
00811749021900Massage Form® Shaper Attach11485-06-BH2020-05-15
00811749021917Massage Form® Shaper Attach11485-07-BH2020-05-15
00811749021924Massage Form® Shaper Attach11485-08-BH2020-05-15
00811749021931Massage Form® Shaper Attach11485-09-BH2020-05-15
00811749021948Massage Form® Shaper Attach11485-10-BH2020-05-15
00811749021955Massage Form® Shaper Attach11485-11-BH2020-05-15
00811749021962Massage Form® Shaper Attach11485-12-BH2020-05-15
00812027017608Massage Form® Attach10475-01-BH2020-05-15
00812027017615Massage Form® Attach10475-02-BH2020-05-15
00812027017622Massage Form® Attach10475-03-BH2020-05-15

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
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