Catalog Number

9084-21

Brand Name

OmniTrustTM

Version/Model Number

9084-21

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

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

9bc05a3c-4628-4b80-ad8d-40fd825ba32d

Public Version Date

September 04, 2019

Public Version Number

1

DI Record Publish Date

August 27, 2019

Package DI Number

50810572006424

Quantity per Package

12

Contains DI Package

00810572006429

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton