Duns Number:631825841
Device Description: An optimized staining technique for assessment of sperm vitality. For use with Assisted R An optimized staining technique for assessment of sperm vitality. For use with Assisted Reproduction Technology (ART)
Catalog Number
SVS-010
Brand Name
Nidacon
Version/Model Number
SpermVitalStain
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
HYB
Product Code Name
Eosin Y
Public Device Record Key
8639a6de-a8b2-457d-9986-70e9cad67d9c
Public Version Date
March 29, 2018
Public Version Number
2
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 |