Catalog Number

-

Brand Name

OEM

Version/Model Number

GSF2000

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

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

34113f85-1434-4661-883f-c9b0a61c6150

Public Version Date

May 21, 2020

Public Version Number

1

DI Record Publish Date

May 13, 2020

Package DI Number

00851685006258

Quantity per Package

10

Contains DI Package

10851685006255

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE