Catalog Number

9012-34

Brand Name

OmniTrustTM

Version/Model Number

9012-34

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

e8778624-b4e7-4756-b032-1df7f40e1d97

Public Version Date

September 04, 2019

Public Version Number

1

DI Record Publish Date

August 27, 2019

Package DI Number

50810572006066

Quantity per Package

20

Contains DI Package

00810572006061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton