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.
Catalog Number
-
Brand Name
SpermFreeze SSP
Version/Model Number
SSP62.5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 05, 2022
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
c3e938fa-81c4-4364-82e3-b57db3cfdb8b
Public Version Date
May 06, 2022
Public Version Number
2
DI Record Publish Date
July 06, 2021
Package DI Number
05411967003457
Quantity per Package
1
Contains DI Package
05411967003440
Package Discontinue Date
-
Package Status
Not 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 |