Duns Number:008513913
Device Description: 2" square electrodes with lead wires, 4 electrodes/pkg.
Catalog Number
2705
Brand Name
V Trode, 2" square
Version/Model Number
2705
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
bd85317a-7cf5-406b-82f3-4de67a512265
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
10816864020316
Quantity per Package
10
Contains DI Package
00816864020319
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. | 57 |