Catalog Number

VAML028-06

Brand Name

Halyard

Version/Model Number

VAML028-06_0002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OJG

Product Code Name

Neurological tray

Public Device Record Key

4f5b794f-afc9-46b8-b12e-26590680cc9a

Public Version Date

August 09, 2022

Public Version Number

1

DI Record Publish Date

August 01, 2022

Package DI Number

20809160379124

Quantity per Package

2

Contains DI Package

10809160379127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-