Catalog Number

4818-32012

Brand Name

Forward

Version/Model Number

4818-32012

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

-

Product Code

PYI

Product Code Name

Thoracic Catheter Insertion Tray

Public Device Record Key

178cce57-2dfe-429a-a563-63189188ed80

Public Version Date

August 21, 2020

Public Version Number

1

DI Record Publish Date

August 13, 2020

Package DI Number

00850015884078

Quantity per Package

12

Contains DI Package

00860000925396

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-