Catalog Number

F-4444

Brand Name

FOURTE Expander Fill System

Version/Model Number

F-4444

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

K161483

Product Code

LCJ

Product Code Name

Expander, Skin, Inflatable

Public Device Record Key

3d2fa2ae-2bd4-448a-a631-ae7608d12358

Public Version Date

September 23, 2019

Public Version Number

2

DI Record Publish Date

January 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-