Duns Number:418415568
Device Description: Disposable Bipolar Probe 2 x 100mm x 0.75mm electrodes; 1.9m wire with DIN42802 connectors
Catalog Number
-
Brand Name
Neurosign V4
Version/Model Number
5885-00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
7f29cf5b-8a19-4712-a9bf-6d5f660f4815
Public Version Date
July 12, 2022
Public Version Number
1
DI Record Publish Date
July 04, 2022
Package DI Number
08718375869512
Quantity per Package
1
Contains DI Package
08718375869505
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfbox
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 429 |