Duns Number:927071162
Device Description: Leadwires (Set) - Tens/EMS/IF Unit Leadwires, 2 sets, 48'', Safety Plug, Black & Red Color Leadwires (Set) - Tens/EMS/IF Unit Leadwires, 2 sets, 48'', Safety Plug, Black & Red Coloring Wires, 500 Sets/ Master Case
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
Leadwires (Set)
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
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
8cf76685-3fcb-4c97-b515-9e0c90437112
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 08, 2016
Package DI Number
20817325021641
Quantity per Package
2
Contains DI Package
10817325021644
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |