Duns Number:305682023
Device Description: Needle Electrode Length: 30 mm (1.2") Pre-attached Leadwire: 76 cm (30") Hub Colour: Purpl Needle Electrode Length: 30 mm (1.2") Pre-attached Leadwire: 76 cm (30") Hub Colour: Purple
Catalog Number
74430-36/10
Brand Name
Neuroline InojectNeurology Needle Electrodes
Version/Model Number
74430-36/10
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
IKT
Product Code Name
Electrode, needle, diagnostic electromyograph
Public Device Record Key
83c640f1-fc33-4f6b-88dd-5677e628a63c
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
05707480001019
Quantity per Package
16
Contains DI Package
05707480023059
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 |