Duns Number:305682023
Device Description: Non Gelled Electrodes SC Connector Lead Wire Length: 10 cm (4")
Catalog Number
72501-SC/12
Brand Name
Neuroline 725Neurology Surface Electrodes
Version/Model Number
72501-SC/12
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2021
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
24764480-73f2-42f4-bdb4-d515e9fca037
Public Version Date
October 06, 2021
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
05707480000777
Quantity per Package
8
Contains DI Package
05707480029341
Package Discontinue Date
October 05, 2021
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |