Duns Number:493047487
Device Description: The SCINUS consists of a cabinet that encloses a temperature-controlled environment where The SCINUS consists of a cabinet that encloses a temperature-controlled environment where a Single Use Bag can be mounted on a mixing Rocker.At the front of the cabinet, the transparent door allows access to the internal area. When opening the transparent front door, the motor of the Rocker will be switched off. In this way, a hazardous situation is prevented.At the left side of the SCINUS front panel, the Emergency Stop button is located, together with the Illumination button and the Control Panel (touch screen display that is used as Graphical User Interface).On the top of the SCINUS, four mounting positions are available for insertion of lifting lugs. The mounting positions are covered and lifting lugs are not provided with the system.
Catalog Number
-
Brand Name
Scinus Cell Expansion System
Version/Model Number
VCL3123001
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
KJF
Product Code Name
System, Suspension, Cell Culture
Public Device Record Key
7c23bdfd-29fd-4436-978c-812aed1be14d
Public Version Date
December 16, 2020
Public Version Number
1
DI Record Publish Date
December 08, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |