Catalog Number

-

Brand Name

MYO/Wire® Ultra-Thin Temporary Pacing Wires

Version/Model Number

VF608ABB

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

e8f7e4ae-4b0c-42be-beb5-e7b0f54526ca

Public Version Date

February 04, 2019

Public Version Number

5

DI Record Publish Date

November 11, 2015

Package DI Number

08718627411889

Quantity per Package

20

Contains DI Package

08718627411872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-