Catalog Number

-

Brand Name

Easy@Home Disposable Plastic Urine Specimen Cups (50- pack)

Version/Model Number

EZW-LH3C50

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

CEP

Product Code Name

Radioimmunoassay, Luteinizing Hormone

Public Device Record Key

8605e01c-8c21-438e-ada6-7d43ebda1343

Public Version Date

August 01, 2018

Public Version Number

1

DI Record Publish Date

July 01, 2018

Package DI Number

10855944007359

Quantity per Package

36

Contains DI Package

00855944007352

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton