Duns Number:305682023
Device Description: Solid Gel Electrodes SC Connector Lead Wire Length: 10 cm (4")
Catalog Number
70001-SC/12
Brand Name
Neuroline 700Neurology Surface Electrodes
Version/Model Number
70001-SC/12
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"
Yes
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
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
7be4d73f-ef93-46ba-961b-8d80d8ba419d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
05707480028528
Quantity per Package
20
Contains DI Package
05707480028535
Package Discontinue Date
-
Package Status
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |