Catalog Number

-

Brand Name

BF-7

Version/Model Number

TENS

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

bd9ab22c-39f6-4335-aba1-1ed23e74f370

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 03, 2016

Package DI Number

30816625020061

Quantity per Package

4

Contains DI Package

10816625020067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case