Duns Number:690568050
Device Description: ELEFIX, 1 SAMPLE TUBE (CONDUCTIVE EEG PASTE)
Catalog Number
A/ELEFIX-SAMPLE
Brand Name
Elefix
Version/Model Number
A/ELEFIX-SAMPLE
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
-
Product Code
GYB
Product Code Name
MEDIA, ELECTROCONDUCTIVE
Public Device Record Key
91a577df-0896-44f6-b748-15a5b920e8aa
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
August 29, 2017
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 |
---|---|---|
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. | 461 |