Catalog Number

FX500-1

Brand Name

Composi-Tight®

Version/Model Number

FX500-1

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"

-

For Single-Use

-

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

-

Product Code

JEP

Product Code Name

Retainer, Matrix

Public Device Record Key

4512a92f-b70c-4de6-bbcb-f3087b2aacdc

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Package DI Number

10810038094530

Quantity per Package

2

Contains DI Package

00810038094533

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

FX500