Duns Number:373904101
Device Description: FertiCult™ Mineral Oil - MINOIL500P (500ml in PETG bottle) FertiCult™ Mineral Oil is pre-w FertiCult™ Mineral Oil - MINOIL500P (500ml in PETG bottle) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil.For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com)
Catalog Number
-
Brand Name
FertiCult Mineral Oil
Version/Model Number
MINOIL500P
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
-
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
124089d8-89ca-46e0-8870-061d438a3dbe
Public Version Date
May 06, 2022
Public Version Number
3
DI Record Publish Date
November 06, 2018
Package DI Number
05411967001163
Quantity per Package
1
Contains DI Package
05411967000883
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |