Catalog Number
6020
Brand Name
Tech-Med
Version/Model Number
6020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 21, 2017
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
K062675,K062675
Product Code
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
e4b4d727-7d75-4997-9ff8-10356c3fe0fc
Public Version Date
May 23, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20665973017116
Quantity per Package
400
Contains DI Package
00665973017112
Package Discontinue Date
February 21, 2017
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |
| U | Unclassified | 1 |