Catalog Number

113-04

Brand Name

OmniTrustTM

Version/Model Number

113-04

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)

Yes

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

LYY

Product Code Name

Latex patient examination glove

Public Device Record Key

cf962502-d40d-422a-a2ff-60ea2fea1bae

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

August 27, 2019

Package DI Number

50810572001153

Quantity per Package

10

Contains DI Package

00810572001158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton