Catalog Number

-

Brand Name

MediMax Tech

Version/Model Number

RMC100 Cables for Needle 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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

a0edacf5-c4a6-468c-a812-46dbcfe8e8b2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

10817325022122

Quantity per Package

200

Contains DI Package

00817325022125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case