Catalog Number

VTX992

Brand Name

Adenna

Version/Model Number

VTX992

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

K072228,K072228,K072228

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

e6e0b92a-7aa8-4ca4-984d-aedca32abc33

Public Version Date

April 28, 2020

Public Version Number

1

DI Record Publish Date

April 20, 2020

Package DI Number

10653195009920

Quantity per Package

10

Contains DI Package

00653195009923

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box