Duns Number:315234102
Device Description: V-OIL is a ready-to-use pre-washed, light paraffin oil for use as an overlay for culture o V-OIL is a ready-to-use pre-washed, light paraffin oil for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedure to prevent the evaporation of water and protects the media against changes in osmolality and pH. Culture of embryos in small volumes of medium under oil helps to enhance rates of embryonic development.
Catalog Number
V-OIL-500P
Brand Name
V-OIL
Version/Model Number
V-OIL-500P
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
QKI
Product Code Name
Media, Reproductive, Exempt
Public Device Record Key
105d8dd7-763b-4f66-9034-5f204d5e136f
Public Version Date
April 12, 2022
Public Version Number
1
DI Record Publish Date
April 04, 2022
Package DI Number
04260650070631
Quantity per Package
1
Contains DI Package
04260650071331
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 |