Duns Number:500375274
Device Description: 20mm x 0.3mm needle electrode; 1m cable with TP DIN42802 connector
Catalog Number
-
Brand Name
Neurosign Disposable Single Electrode
Version/Model Number
1705-00-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
d340a405-e43c-4cf9-8c3d-3a525b3858c4
Public Version Date
August 30, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
15060229530346
Quantity per Package
20
Contains DI Package
05060229530349
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 |