Catalog Number

-

Brand Name

VersaFlex

Version/Model Number

VF500S

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

K172015,K172015,K172015

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

6f043d4b-80ca-4ca6-b8c0-8a86a5cf1cf2

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

00811114031190

Quantity per Package

10

Contains DI Package

00811114031145

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton