Duns Number:824632087
Device Description: Microdialysis analyzer using substance specific reagents to evaluate the concentrations in Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysis sampling system (Catheter, 106 MD Pump and Microvials).
Catalog Number
8003295
Brand Name
ISCUSflex
Version/Model Number
Clinical
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
GWM
Product Code Name
Device, Monitoring, Intracranial Pressure
Public Device Record Key
f026ada0-837e-4c85-a167-a8d8f7f1bbad
Public Version Date
October 07, 2019
Public Version Number
3
DI Record Publish Date
September 24, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |