Duns Number:315234102
Device Description: V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
Catalog Number
V-OSM-10
Brand Name
V-ONESTEP
Version/Model Number
V-OSM-10
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
e429ee05-722c-4b02-8512-0ccbec63ad7e
Public Version Date
April 12, 2022
Public Version Number
1
DI Record Publish Date
April 04, 2022
Package DI Number
04260650071713
Quantity per Package
1
Contains DI Package
04260650070013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Board box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |