Duns Number:418415568
Device Description: Reusable Concentric EMG Needle Electrode, Pt/Ir electrode, red
Catalog Number
-
Brand Name
Technomed Europe
Version/Model Number
TE/D12-301
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 08, 2021
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
-
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
cc748a47-e860-41f4-ab14-496318f237db
Public Version Date
December 09, 2021
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 429 |