Duns Number:305682023
Device Description: Needle Electrode Length: 12 mm (0.5") Leadwire Length: 100 cm (40") Each box of 24 consist Needle Electrode Length: 12 mm (0.5") Leadwire Length: 100 cm (40") Each box of 24 consists of 4 pieces in each of the colors: White, Green, Blue, Yellow, Red, Black
Catalog Number
74512-100/24
Brand Name
Neuroline SubdermalNeurology Needle Electrodes
Version/Model Number
74512-100/24
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
9d93a706-a08e-4436-b96b-5fe66bf214e5
Public Version Date
July 16, 2018
Public Version Number
3
DI Record Publish Date
March 16, 2017
Package DI Number
05707480135264
Quantity per Package
16
Contains DI Package
05707480135271
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 |