Duns Number:039143201
Device Description: 24-pack of Ten20 Conductive Paste Single-Use Cups
Catalog Number
10-20-1
Brand Name
Ten20 Conductive Paste
Version/Model Number
10-20-1
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
Product Code
GYB
Product Code Name
Media, Electroconductive
Public Device Record Key
c35f5140-ac6e-4a33-99b8-0b08e85e5c20
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
May 15, 2018
Package DI Number
20891893002271
Quantity per Package
24
Contains DI Package
10891893002274
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |