Catalog Number

EPW445

Brand Name

Empower

Version/Model Number

EPW445

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

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

67bababb-68fa-45f0-ab60-edadd3297c12

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 17, 2020

Package DI Number

06531958244580

Quantity per Package

10

Contains DI Package

00653195824458

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box