Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

Elite- 75RdTSBA(NS) : 75mmRd Tricot Silver Film Electrodes

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

68ff5e75-66f2-4ca3-a32c-a09111046f6f

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

November 20, 2019

Package DI Number

30817120021423

Quantity per Package

5

Contains DI Package

20817120021426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case