Duns Number:305424269
Device Description: PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase In HEPES-buffered HTF
Catalog Number
-
Brand Name
PureCeption 24 - Determination Bi-Layer Kit
Version/Model Number
ART-2024
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)
-
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
d25b026a-d599-458f-b6d8-c6932a0133e5
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 |