Duns Number:927071162
Device Description: RNC150: Alligator Clips - Cables for Disposable Surface Electrodes. 1.5m in length. (3 pcs RNC150: Alligator Clips - Cables for Disposable Surface Electrodes. 1.5m in length. (3 pcs per set/ Red, Black, and Green).
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
RNC150: Alligator Clips
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
-
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
278b6a8d-f0c2-4cb5-81cc-69bd458e80a2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 27, 2016
Package DI Number
10817325022634
Quantity per Package
100
Contains DI Package
00817325022637
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 |