Duns Number:002111896
Device Description: Supplier PN: S5050C2WC-TNeurostimulation Electrode
Catalog Number
700000543
Brand Name
BioTens
Version/Model Number
700000543
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
c7fd8f4e-5c4f-4f19-88ea-0d4962ca8661
Public Version Date
May 19, 2022
Public Version Number
2
DI Record Publish Date
April 11, 2022
Package DI Number
30009336010173
Quantity per Package
80
Contains DI Package
10009336010179
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |