Catalog Number

PRM254199

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

PRM254199

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"

Yes

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Public Device Record Key

7793b693-6442-4085-a4d3-2eadefa0cac4

Public Version Date

March 02, 2021

Public Version Number

1

DI Record Publish Date

February 22, 2021

Package DI Number

30888277189878

Quantity per Package

6

Contains DI Package

10888277189874

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX