Duns Number:002449593
Device Description: Spectra 360 Electrode Gel , 250 gram tube
Catalog Number
12-08
Brand Name
SPECTRA
Version/Model Number
ELECTRODE GEL
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
14d27e34-9dfd-48c2-b63d-2cfcb96b1087
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
December 19, 2016
Package DI Number
20855683006207
Quantity per Package
6
Contains DI Package
10855683006200
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |