ABC Nipple

Basic Information

• Brand Name: ABC Nipple
• Primary DI: 00811749024826
• Version / Model: 906-M-TW
• Company Name: AMERICAN BREAST CARE, L.P.
• Labeler DUNS: 132124061
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-15
• Public Version: 1
• Public Version Date: 2020-05-25
• Public Version Status: New
• Public Device Record Key: 58b0bc28-13a0-4db1-8592-0b3785cee2c5

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 Tawny

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCZ	Prosthesis, Breast, External, Used With Adhesive	General, Plastic Surgery	878.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47336	Nipple prosthesis, external	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811749024826	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.75	Inch