FDA.reportPublic FDA data

ABC Diamond Attach

Primary DI
00810008657904
Brand
ABC Diamond Attach
Company
AMERICAN BREAST CARE, L.P.
Model
10487-02-BH
Device description
External Breast Prosthesis with Adhesive 10487 ABC Diamond Attach Attach The remarkable cooling comfort of ABC’s Diamond Technology is now available in an attachable breast form; ABC’s Diamond Attach! Our specialized diamond pattern minimizes perspiration, increases evaporation rate during activity, while ABC’s integrated adhesive prevents shifting for secure comfort that lasts! Enjoy the extraordinary comfort & and secure fit of ABC’s Diamond Attach.
Published
2026-10-09
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

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
00810008657904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008657904008100086579048100086579040810008657904

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Regulatory Flags#

DUNS number
132124061
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810008657911ABC Diamond Attach10487-03-BH2026-10-09
00810008657928ABC Diamond Attach10487-04-BH2026-10-09
00810008657935ABC Diamond Attach10487-05-BH2026-10-09
00810008657942ABC Diamond Attach10487-06-BH2026-10-09
00810008657959ABC Diamond Attach10487-07-BH2026-10-09
00810008657966ABC Diamond Attach10487-08-BH2026-10-09
00810008657973ABC Diamond Attach10487-09-BH2026-10-09
00810008657980ABC Diamond Attach10487-10-BH2026-10-09
00810008657997ABC Diamond Attach10487-11-BH2026-10-09
00811749024758ABC Nipple906-S-IV2020-05-15
00811749024765ABC Nipple906-M-IV2020-05-15
00811749024772ABC Nipple906-L-IV2020-05-15
00811749024789ABC Nipple906-S-BH2020-05-15
00811749024796ABC Nipple906-M-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

Other Devices Sharing Product Codes#

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