Duns Number:418415568
Device Description: Reusable Connecting Leads, for subdermal needle electrodes, 1mm female to DIN 42802, 6 pie Reusable Connecting Leads, for subdermal needle electrodes, 1mm female to DIN 42802, 6 pieces
Catalog Number
-
Brand Name
Technomed Europe
Version/Model Number
TE/S81-434/01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 10, 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
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
f5fdd140-8f6e-410f-9abe-fcbfcbc4087b
Public Version Date
March 11, 2021
Public Version Number
3
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 |