Duns Number:631825841
Device Description: The product is intended to be used for the separation and purification of spermatozoa by d The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples,where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).
Catalog Number
PSK-020
Brand Name
Nidacon
Version/Model Number
PureSperm® 40/80
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
K002623
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
0f841437-03c1-4639-b396-e636e1d3bb07
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 15, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |