Duns Number:631825841
Device Description: The product is intended to be used for diluting PureSperm® sperm separation medium to pr The product is intended to be used for diluting PureSperm® sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.
Catalog Number
PSB-100
Brand Name
Nidacon
Version/Model Number
PureSperm® Buffer
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
K011606
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
45c19372-c78b-4fb3-b56b-51ad52a0c289
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 |