Duns Number:082930884
Device Description: Leica Biosystems CytoVision Dell Ultrasharp U2415 Monitor
Catalog Number
-
Brand Name
Leica Biosystems CytoVision Dell Ultrasharp U2415 Monitor
Version/Model Number
23MON0024
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
JOY
Product Code Name
DEVICE, AUTOMATED CELL-LOCATING
Public Device Record Key
99de3287-e73d-42c6-a999-2726ba38f01b
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
September 17, 2016
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 206 |