Catalog Number

-

Brand Name

MYO/Wire® Ultra-Thin Temporary Pacing Wires

Version/Model Number

VF2008ABBWD

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

K033858,K033858

Product Code

LDF

Product Code Name

ELECTRODE, PACEMAKER, TEMPORARY

Public Device Record Key

3ec014b4-3772-4a81-b0c8-d816f2978fe7

Public Version Date

February 04, 2019

Public Version Number

5

DI Record Publish Date

November 11, 2015

Package DI Number

08718627411841

Quantity per Package

10

Contains DI Package

08718627411834

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-