Catalog Number

-

Brand Name

Elite Gauze

Version/Model Number

ELITE-GZ4X4S

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)

-

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

fca3a73d-2ba6-4d9e-9819-e60bb7c55356

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

April 21, 2021

Package DI Number

00840155407718

Quantity per Package

25

Contains DI Package

00840155407640

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box