Catalog Number

B PXDL 0500 R00401 US

Brand Name

U.S. Cotton

Version/Model Number

B PXDL 0500 R00401 US

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRL

Product Code Name

Fiber, Medical, Absorbent

Public Device Record Key

fd059735-5500-4699-9cc2-0c9b1bd7b5f0

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

February 28, 2020

Package DI Number

10095859110502

Quantity per Package

4

Contains DI Package

00095859110505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case