Duns Number:305424269
Device Description: ART-2004: PureCeption 4 - Determination Kit with Sperm Washing Medium. (3x12 ml)ART-2016: ART-2004: PureCeption 4 - Determination Kit with Sperm Washing Medium. (3x12 ml)ART-2016: PureCeption 16 - Determination Kit with Sperm Washing Medium. 4x(3x12 ml)
Catalog Number
-
Brand Name
PureCeption 4 - Determination Kit
Version/Model Number
ART-2004
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)
-
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
5238d2bb-8c70-4b99-9340-e8b05a2ca802
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 28, 2017
Package DI Number
60888937818569
Quantity per Package
4
Contains DI Package
60888937818521
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
ART-2016
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |