FDA.report

ABC Nipple

Primary DI
00811749024765
Brand
ABC Nipple
Company
AMERICAN BREAST CARE, L.P.
Model
906-M-IV
Device description
Nipple prosthesis, external 906 ABC Nipple Made of soft silicone with an adhesive back, this nipple prosthesis can be securely attached to a breast form, shaper, or reconstructed breast. Size Medium Color Ivory
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
00811749024765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811749024765008117490247658117490247650811749024765

GMDN Terms

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

TypeValueUnit
Outer Diameter1.75Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number
132124061
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
00811749024758ABC Nipple906-S-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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