Duns Number:500375274
Device Description: 2 x 70mm x 0.75mm electrodes; 1.9m twisted wire with DIN42802 connectors, blue wire is act 2 x 70mm x 0.75mm electrodes; 1.9m twisted wire with DIN42802 connectors, blue wire is active
Catalog Number
-
Brand Name
Neurosign Disposable Bipolar Probe, Precision
Version/Model Number
3604-00-TE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 2018
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
a3ea183c-faaa-4712-81b3-b1373e2afc70
Public Version Date
September 20, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
15060229530704
Quantity per Package
10
Contains DI Package
05060229530707
Package Discontinue Date
February 25, 2018
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |