Catalog Number

S SWPLC 0170 R04801 USC

Brand Name

U.S. Cotton

Version/Model Number

S SWPLC2 0170 R04801 USC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 09, 2022

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

KXF

Product Code Name

Applicator, Absorbent Tipped, Non-Sterile

Public Device Record Key

9a7653e6-c8e6-4c03-ba21-fddec7ddfd27

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 13, 2021

Package DI Number

10048341050145

Quantity per Package

48

Contains DI Package

00048341050148

Package Discontinue Date

June 09, 2022

Package Status

Not in Commercial Distribution

Package Type

Case