Duns Number:418415568
Device Description: Disposable Subdermal Needle Electrode, 14x0.38mm needle, 2.5m wire, 4x6 colors, 24pcs (Dis Disposable Subdermal Needle Electrode, 14x0.38mm needle, 2.5m wire, 4x6 colors, 24pcs (Disposable 6 color Natus Ultra Subdermal Needle Electrode)
Catalog Number
-
Brand Name
Natus
Version/Model Number
019-477000
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
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
f6ffcfe8-68a1-4100-ab87-ac3f7e53af10
Public Version Date
April 09, 2021
Public Version Number
1
DI Record Publish Date
April 01, 2021
Package DI Number
08718375867273
Quantity per Package
24
Contains DI Package
08718375867280
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 429 |