Catalog Number

V-OSM-20

Brand Name

V-ONESTEP

Version/Model Number

V-OSM-20

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

-

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

-

FDA Premarket Submission

-

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

5c5712be-f667-4487-80d3-d1890b947add

Public Version Date

April 13, 2022

Public Version Number

1

DI Record Publish Date

April 05, 2022

Package DI Number

04260650070914

Quantity per Package

1

Contains DI Package

04260650071614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Board box