Duns Number:305424269
Device Description: Quinns Advantage Sperm Freezing Medium. 6x12 ml ART-8020 Quinns Advantage Sperm Freezing M Quinns Advantage Sperm Freezing Medium. 6x12 ml ART-8020 Quinns Advantage Sperm Freezing Medium
Catalog Number
-
Brand Name
Quinns Advantage Sperm Freezing Medium
Version/Model Number
ART-8022
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
Yes
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
76c598c6-1259-48e6-a4b5-429caa21f7ca
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 28, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 93 |