Catalog Number

215-43

Brand Name

OmniTrustTM

Version/Model Number

215-43

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

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

3c7cd563-f3bb-4d69-880f-6773a3e021ad

Public Version Date

December 28, 2021

Public Version Number

1

DI Record Publish Date

December 20, 2021

Package DI Number

50810572004215

Quantity per Package

10

Contains DI Package

00810572004210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton