Duns Number:373904101
Device Description: SpermFreeze SSPSpermFreeze SSP is a medium for freezing human sperm. SpermFreeze has a sh SpermFreeze SSPSpermFreeze SSP is a medium for freezing human sperm. SpermFreeze has a shelf life of 18 months.For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)
Catalog Number
-
Brand Name
SpermFreeze SSP
Version/Model Number
SSP125
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
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
97199523-2d3b-403e-9a00-7389b4a7637a
Public Version Date
May 08, 2020
Public Version Number
1
DI Record Publish Date
April 30, 2020
Package DI Number
05411967000142
Quantity per Package
1
Contains DI Package
05411967001408
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |