Duns Number:190094230
Device Description: MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL - Oil for MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL - Oil for Tissue Culture is used in covering tissue culture in in vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Catalog Number
2011
Brand Name
MINERAL OIL - Oil for Tissue Culture
Version/Model Number
2011
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053494
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
b4b82171-573d-4b90-9fab-de7405c4b6f7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |