Duns Number:039143201
Device Description: 3-pack of Ten20 Conductive Paste Single-Use Cups
Catalog Number
10-20-1S
Brand Name
Ten20 Conductive Paste
Version/Model Number
10-20-1S
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
Product Code
GYB
Product Code Name
Media, Electroconductive
Public Device Record Key
8656f053-3897-4121-8fa4-c812d8ca9d7c
Public Version Date
October 14, 2021
Public Version Number
1
DI Record Publish Date
October 06, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |