Catalog Number

-

Brand Name

Endurance

Version/Model Number

EDC905-BX

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

4f548c07-7d03-4e41-a17b-a8bc2a2f1cbb

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

October 01, 2022

Package DI Number

20857420007331

Quantity per Package

10

Contains DI Package

10857420007334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case