FDA.report

Massage Form® Shaper Attach

Primary DI
00811749021887
Brand
Massage Form® Shaper Attach
Company
AMERICAN BREAST CARE, L.P.
Model
11485-04-BH
Device description
External Breast Prosthesis with Adhesive 11485 Massage Form® Shaper Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy 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 silhouette Size 4 Blush Color
Published
2020-05-15
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

Related Records

Product Codes

CodeName
KCZProsthesis, Breast, External, Used With Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KCZProsthesis, Breast, External, Used With AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811749021887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811749021887008117490218878117490218870811749021887

GMDN Terms

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

TypeValueUnit
Total Volume120Milliliter

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
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
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
00812027017608Massage Form® Attach10475-01-BH2020-05-15
00812027017615Massage Form® Attach10475-02-BH2020-05-15
00812027017622Massage Form® Attach10475-03-BH2020-05-15

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