Catalog Number

UH-3

Brand Name

ORI

Version/Model Number

UH-3

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KPY

Product Code Name

Shield, Protective, Personnel

Public Device Record Key

378ee62e-38e7-4f79-bf2f-28cfef5107a4

Public Version Date

April 06, 2020

Public Version Number

2

DI Record Publish Date

January 07, 2019

Package DI Number

10854150007238

Quantity per Package

50

Contains DI Package

00854150007231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case