Catalog Number

401-101A

Brand Name

AART Malar 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

K021419

Product Code

LZK

Product Code Name

IMPLANT, MALAR

Public Device Record Key

6b8edcdd-ec3e-44ba-bcdf-fdb981e10a26

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-