Duns Number:789127011
Device Description: 30RdTSBA- 30mm Round Tricot Elite Silver Backing Tens Electrodes, with Aluminum pouches. 30RdTSBA- 30mm Round Tricot Elite Silver Backing Tens Electrodes, with Aluminum pouches.
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
30RdTSBA
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
28637ed8-8115-4927-af5b-be0d0ba8b4a6
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
February 23, 2017
Package DI Number
30817120020655
Quantity per Package
5
Contains DI Package
20817120020658
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 |