Duns Number:066689993
Device Description: 2" X 3.5" RECTANGULAR WHITE FABRIC CARBON ELECTRODE FOR CUSTOM STICKER, 4/PK
Catalog Number
CUS620
Brand Name
BodyMed
Version/Model Number
CUS620
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
K092546,K092546,K092546
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
e4f852b7-4a46-4424-a17f-ed461b78d4ac
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
September 05, 2016
Package DI Number
10815802015568
Quantity per Package
45
Contains DI Package
00815802015561
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |