Duns Number:827221698
Device Description: 2" x 2", Tan Cloth CanDo Electrode
Catalog Number
-
Brand Name
CanDo Electrode - Fabrication Enterprises
Version/Model Number
13-1291-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
14f44c26-b1aa-4596-9497-9c68e8817be5
Public Version Date
February 09, 2022
Public Version Number
2
DI Record Publish Date
January 01, 2022
Package DI Number
50714905710043
Quantity per Package
50
Contains DI Package
00714905710048
Package Discontinue Date
January 01, 2022
Package Status
Not 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 |