Duns Number:508663101
Device Description: The CellaVision Server Software is a network optimization design to create workflow effice The CellaVision Server Software is a network optimization design to create workflow efficency in lager organizations and enables easy data transfer from all connected analyzers to a centralized database residing on a single server.
Catalog Number
CSS-0000NG
Brand Name
CellaVision® Server Softwaren, Upgrade to next generation
Version/Model Number
CSS-0000NG
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OUG
Product Code Name
Medical Device Data System
Public Device Record Key
7d868e1a-15dc-4145-a89b-1bdcca11a974
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
February 19, 2019
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |