Duns Number:373904101
Device Description: SpermFreeze (SPF) (20 ml) SpermFreeze is a medium for the cryopreservation of human sperm
Catalog Number
-
Brand Name
SpermFreeze
Version/Model Number
SPF
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
6e22a920-a217-40ad-84ec-46b526193a18
Public Version Date
April 11, 2022
Public Version Number
4
DI Record Publish Date
May 19, 2016
Package DI Number
05411967000265
Quantity per Package
5
Contains DI Package
05411967002009
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 |