Duns Number:874257488
Device Description: Disposable Bar Electrodes, 12mm x 18mm contact area 100 (10 sets of 10/box) Use with all Disposable Bar Electrodes, 12mm x 18mm contact area 100 (10 sets of 10/box) Use with alligator-clip lead wires
Catalog Number
-
Brand Name
Natus
Version/Model Number
N6003
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
-
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
37acc713-20f6-4f5a-ad57-ef34d65afe41
Public Version Date
May 28, 2021
Public Version Number
4
DI Record Publish Date
September 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |