Duns Number:554479334
Device Description: Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and culture tothe two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washingand handling sperm and collected oocytes after aspiration prior to IVF procedures. Dewin FertilizationMedium is not intended for use in intrauterine insemination procedures.
Catalog Number
-
Brand Name
DEWIN
Version/Model Number
9340
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
K212426
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
bc83c264-fde8-4a6e-ad8f-e98946229dc0
Public Version Date
July 18, 2022
Public Version Number
1
DI Record Publish Date
July 08, 2022
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. | 10 |