Catalog Number

P121981

Brand Name

MEDLINE

Version/Model Number

P121981

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)

Yes

Over the Counter (OTC)

-

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

91966b8b-ad54-4adc-b080-97ca308ed960

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

April 03, 2020

Package DI Number

40888277903525

Quantity per Package

30

Contains DI Package

10888277903524

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE