Catalog Number

-

Brand Name

PureShield

Version/Model Number

PS503

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

628fa1a7-93ec-44d3-a8aa-a820b5e6f3fd

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 22, 2022

Package DI Number

20857420007164

Quantity per Package

10

Contains DI Package

10857420007167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case