FDA.reportPublic FDA data

Massage Form® Attach

Primary DI
00812027017615
Brand
Massage Form® Attach
Company
AMERICAN BREAST CARE, L.P.
Model
10475-02-BH
Device description
External Breast Prosthesis with Adhesive 10475 Massage Form® Attach Patented Massage Technology- Massages, Hugs, CoolsEnjoy the cooling comfort and secure wear of the Massage Form ® Attach. ABC’s integrated adhesive keeps this lightweight formsecurely in place for a natural look and comfortable fit. Featuring ABC’s Patented Massage Technology, specialized channelsencourage airflow, helping to reduce heat retention and provide a soothing touch. This prosthesis is especially great for womenexperiencing symptoms associated with Lymphedema.Size 2Blush Color
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
00812027017615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812027017615008120270176158120270176150812027017615

GMDN Terms#

Term, Definition table
TermDefinition
Breast prosthesis, externalAn external device used 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 Volume160Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
132124061
Device count
1
Premarket exempt
true
Serial number
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
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
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
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
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