AccessGUDID - DEVICE: ABC Nipple (00811749024802)

GUDID

Device Identifier (DI) Information

Brand Name: ABC Nipple
Version or Model: 906-L-BH
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERICAN BREAST CARE, L.P.

Primary DI Number: 00811749024802
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 132124061 *Terms of Use

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 Large Color Blush

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCZ	Prosthesis, Breast, External, Used With Adhesive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2 Inch

Device Record Status

Public Device Record Key: b9bfa7d4-332d-440f-b7cb-95c56428cd19
Public Version Date: May 25, 2020
Public Version Number: 1
DI Record Publish Date: May 15, 2020