Duns Number:827221698
Device Description: 2" x 2", Square-White Cloth - 4/pk
Catalog Number
-
Brand Name
MicroBlock Antimicrobial Electrode
Version/Model Number
400-877-MIC
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)
Yes
Over the Counter (OTC)
-
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
35cf6c12-9cfe-46c9-9633-a5b4c7e17bc8
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
June 11, 2020
Package DI Number
30092237902258
Quantity per Package
10
Contains DI Package
00092237902257
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |