Catalog Number

EBTF400600M

Brand Name

Butterfly Pre-wired electrodes

Version/Model Number

EBTF400600M

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K160138

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

dfdbcb4b-e43f-462b-9153-37d0a0a59858

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

March 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-