Duns Number:085932630
Device Description: Injectable Monopolar Needle Electrode, EMG, 125mm x 23g
Catalog Number
242-3125-24TP-1
Brand Name
Chalgren
Version/Model Number
242-3125-24TP-1
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
0f515c35-07f9-45a2-94b7-053e36f6a49c
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
40816020020441
Quantity per Package
10
Contains DI Package
00816020020443
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 66 |