AccessGUDID - DEVICE: AART Pectoralis Implant Sizer (B49050020052A0)

GUDID

Device Identifier (DI) Information

Brand Name: AART Pectoralis Implant Sizer
Version or Model: A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 500-200-5-2A
Company Name: Aart

Primary DI Number: B49050020052A0
Issuing Agency: HIBCC
Commercial Distribution End Date: July 22, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 091356894 *Terms of Use

Device Description: Szr - Pectoral Sty 2 Sz 0 L NS

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
48163	Pectoral implant	An implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of silicone elastomer.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIC	Implant, muscle, pectoralis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021337	000

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 6996cc0b-b8dd-40ed-82be-132d1f08f1e8
Public Version Date: August 22, 2025
Public Version Number: 6
DI Record Publish Date: December 20, 2016