Catalog Number

B PMDL 2000 R00201 US

Brand Name

U.S. Cotton

Version/Model Number

B PMDL 2000 R00201 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

e3aa7bd3-dac0-43a3-a501-6288b51ad03b

Public Version Date

February 22, 2021

Public Version Number

1

DI Record Publish Date

February 13, 2021

Package DI Number

10095859120006

Quantity per Package

2

Contains DI Package

00095859120009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case