Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

4141WCBZGN (ECO)

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

ce289dc8-b873-40db-926d-a3514e627f56

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

August 23, 2017

Package DI Number

30817120021270

Quantity per Package

5

Contains DI Package

20817120021273

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case