Catalog Number

-

Brand Name

Crosstex Premium Cotton-Filled Sponges, Non-Sterile

Version/Model Number

ENCC3

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

fb89c152-c0d5-444d-8cd8-1355470a1eaf

Public Version Date

September 02, 2022

Public Version Number

1

DI Record Publish Date

August 25, 2022

Package DI Number

50732224001185

Quantity per Package

20

Contains DI Package

10732224001187

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-