Duns Number:789127011
Device Description: HiDow Palm Shape Tens Electrodes (2x3in Blue Gel) - 2 pcs per pack/pouch, Multi use self-a HiDow Palm Shape Tens Electrodes (2x3in Blue Gel) - 2 pcs per pack/pouch, Multi use self-adhesive electrodes Blue gel hypo-allergenic,Tens Electrodes with Blue Gel
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
HiDow Palm Shape Tens Electrodes (2x3in Blue Gel)
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
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
07c6fc1b-1235-461c-9e12-8377bec1716b
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
January 17, 2018
Package DI Number
30817120021393
Quantity per Package
5
Contains DI Package
20817120021396
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 103 |