Duns Number:789127011
Device Description: RG02 TSBA - 90x50mm Rectangle (2x4in Rectangle) Tricot Silver Backing Tens Electrodes, wi
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
RG02TSBA
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
f7a49205-097b-4423-9085-5df4ca7554ee
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
October 17, 2016
Package DI Number
30817120020631
Quantity per Package
5
Contains DI Package
20817120020634
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 |