AccessGUDID - DEVICE: Massage Form® Shaper Attach (00811749021962)

GUDID

Device Identifier (DI) Information

Brand Name: Massage Form® Shaper Attach
Version or Model: 11485-12-BH
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERICAN BREAST CARE, L.P.

Primary DI Number: 00811749021962
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 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 12 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: 490 Milliliter

Device Record Status

Public Device Record Key: 595eedd3-3dc3-462b-b46d-0d93ee877230
Public Version Date: July 22, 2021
Public Version Number: 2
DI Record Publish Date: May 15, 2020