OmniTrustTM - Nitrile Examination Glove Powder Free Large - OMNI INTERNATIONAL CORP.

Duns Number:079434709

Device Description: Nitrile Examination Glove Powder Free Large

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More Product Details

Catalog Number

212-23

Brand Name

OmniTrustTM

Version/Model Number

212-23

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

OPJ

Product Code Name

Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs

Device Record Status

Public Device Record Key

c6a5b3d5-2ffe-4815-9b16-961fac784945

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

August 27, 2019

Additional Identifiers

Package DI Number

50810572001191

Quantity per Package

10

Contains DI Package

00810572001196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton

"OMNI INTERNATIONAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2