Catalog Number

74425-30/10

Brand Name

Neuroline InojectNeurology Needle Electrodes

Version/Model Number

74425-30/10

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

IKT

Product Code Name

Electrode, needle, diagnostic electromyograph

Public Device Record Key

e8a3379f-8c2d-4278-a8d6-5f6c73586512

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

05707480023042

Quantity per Package

10

Contains DI Package

05707480023813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-