Catalog Number

AF0508

Brand Name

ARTEFILL

Version/Model Number

8021

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 10, 2016

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P020012,P020012

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Public Device Record Key

996f50aa-fdf7-4925-a78b-e3990b114ce1

Public Version Date

September 14, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2014

Package DI Number

10350224000001

Quantity per Package

5

Contains DI Package

00350224000004

Package Discontinue Date

April 10, 2016

Package Status

Not in Commercial Distribution

Package Type

5 syringe per box