Catalog Number

Not Applicable

Brand Name

Elite Multi-Trauma Dressing

Version/Model Number

ELITE-GZM001

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

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Public Device Record Key

eaa5c768-dc7a-4c08-adb0-28c94bd83782

Public Version Date

April 29, 2021

Public Version Number

1

DI Record Publish Date

April 21, 2021

Package DI Number

00840155407732

Quantity per Package

25

Contains DI Package

00840155407664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case