Catalog Number

-

Brand Name

Cotton Rolls

Version/Model Number

DNCS

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EFN

Product Code Name

COTTON, ROLL

Public Device Record Key

1342b3ee-a718-439a-8783-0d02b92c45f9

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

50732224000102

Quantity per Package

12

Contains DI Package

10732224000104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-