Duns Number:305682023
Device Description: Needle Electrode Length: 38 mm (1.5") Pre-attached Leadwire: 76 cm (30") Hub Colour: Light Needle Electrode Length: 38 mm (1.5") Pre-attached Leadwire: 76 cm (30") Hub Colour: Light Green
Catalog Number
74338-36/40
Brand Name
Neuroline MonopolarNeurology Needle Electrodes
Version/Model Number
74338-36/40
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
5d9bdc1d-b690-413b-bb78-7c6533256173
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
05707480023004
Quantity per Package
40
Contains DI Package
05707480023776
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 |