Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

HiDow Rectangular Shape Tens Electrodes (2x3in BP 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

88345a0d-3ff7-4f0b-859e-561fb1648929

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

January 17, 2018

Package DI Number

30817120021409

Quantity per Package

5

Contains DI Package

20817120021402

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case