Duns Number:067486548
Device Description: TAC GEL Electrically Conductive Adhesive: 10 gm tube
Catalog Number
36-9000-10
Brand Name
Pharmaceutical Innovations
Version/Model Number
TAC GEL Electrically Conductive Adhesive
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GYB
Product Code Name
Media, Electroconductive
Public Device Record Key
e13fd24d-5c05-4ec1-b977-0114061b13f1
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
10300369000107
Quantity per Package
24
Contains DI Package
00300369000100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
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. | 35 |