Catalog Number

500-404-6A

Brand Name

AART Pectoralis Implant

Version/Model Number

A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K021337

Product Code

MIC

Product Code Name

Implant, muscle, pectoralis

Public Device Record Key

593d2531-99cc-4e58-a8c8-d16cfda4d109

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

December 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-