Catalog Number

216-21

Brand Name

OmniTrustTM

Version/Model Number

216-21

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

OPJ

Product Code Name

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Public Device Record Key

d24c923b-0f0f-411c-a57d-32ea7aa18d76

Public Version Date

December 18, 2020

Public Version Number

1

DI Record Publish Date

December 10, 2020

Package DI Number

50810572003836

Quantity per Package

10

Contains DI Package

00810572003831

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton