AccessGUDID - DEVICE: Massage Form® Attach (00812027017622)

GUDID

Device Identifier (DI) Information

Brand Name: Massage Form® Attach
Version or Model: 10475-03-BH
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERICAN BREAST CARE, L.P.

Primary DI Number: 00812027017622
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 132124061 *Terms of Use

Device Description: External Breast Prosthesis with Adhesive 10475 Massage Form® Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy the cooling comfort and secure wear of the Massage Form ® Attach. ABC’s integrated adhesive keeps this lightweight form securely in place for a natural look and comfortable fit. Featuring ABC’s Patented Massage Technology, specialized channels encourage airflow, helping to reduce heat retention and provide a soothing touch. This prosthesis is especially great for women experiencing symptoms associated with Lymphedema. Size 3 Blush Color

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?
35676	External breast prosthesis	An external device intended 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.	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
Total Volume: 205 Milliliter

Device Record Status

Public Device Record Key: 9d434d03-636c-4d5b-a33f-2f6d11c83358
Public Version Date: July 22, 2021
Public Version Number: 2
DI Record Publish Date: May 15, 2020