Duns Number:039143201
Device Description: Single 4oz tube of Ten20 Conductive Paste (unit of use)
Catalog Number
-
Brand Name
Ten20 Conductive Paste
Version/Model Number
10-20-4T; 10-20-4TK
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
K883149,K883149,K883149,K883149,K883149,K883149
Product Code
GYB
Product Code Name
Media, Electroconductive
Public Device Record Key
dc402f8e-8c29-4fd5-b814-8af1bf14fedd
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
30891893002254
Quantity per Package
1
Contains DI Package
00891893002253
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |