FDA.reportPublic FDA data

Massage Form® Shaper Attach

Primary DI
00811749021924
Brand
Massage Form® Shaper Attach
Company
AMERICAN BREAST CARE, L.P.
Model
11485-08-BH
Device description
External Breast Prosthesis with Adhesive11485 Massage Form® Shaper AttachPatented Massage Technology- Massages, Hugs, CoolsEnjoy the soothing caress of ABC’s Massage Form® Shaper Attach. Featuring our patented Massage Technology, this shaper cools as it massages to increase comfort, especially for women experiencing symptoms related to lymphedema. ABC’s integrated adhesive prevents shifting for secure comfort that lasts. This shaper conforms to your body’s curves creating a seamless transition and silhouetteSize 8Blush 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
00811749021924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811749021924008117490219248117490219240811749021924

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 Volume255Milliliter

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
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
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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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