Duns Number:529966489
Device Description: Flexible and easy to fit electrode can be applied to every contour of the human body. You Flexible and easy to fit electrode can be applied to every contour of the human body. You can use the electrodes many times because of its reliable long lasting gel. 2 Electrodes in sealed foil pouch.
Catalog Number
-
Brand Name
Jiajian
Version/Model Number
50*130mm
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090198,K090198,K090198
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
d54f0da4-21e3-4b47-9278-04a747fbeb94
Public Version Date
August 23, 2019
Public Version Number
1
DI Record Publish Date
August 15, 2019
Package DI Number
26972011716004
Quantity per Package
20
Contains DI Package
16972011716007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 123 |
| U | Unclassified | 2 |