Catalog Number

-

Brand Name

Myo/Wire

Version/Model Number

025-400

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

K803086,K803086

Product Code

LDF

Product Code Name

Electrode, Pacemaker, Temporary

Public Device Record Key

f434b3c2-0246-435f-9835-7bafd0e387ab

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2015

Package DI Number

20841291100437

Quantity per Package

24

Contains DI Package

10841291100430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-