Duns Number:824632087
Device Description: Microdialysis catheter (20 kDa cut-off, 100 mm shaft length, 10 mm membrane length) for sh Microdialysis catheter (20 kDa cut-off, 100 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnelation technique.
Catalog Number
P000050
Brand Name
70 Brain Microdialysis Catheter 100/10, 4/pkg
Version/Model Number
100/10
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
Yes
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
6ffc6027-7506-48af-8df4-f55fc5397ee6
Public Version Date
October 07, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
07332699000539
Quantity per Package
4
Contains DI Package
07332699000928
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
White cardboard box
| 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 |