Catalog Number

-

Brand Name

NONE

Version/Model Number

NONE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2019

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

K091410,K091410

Product Code

IKT

Product Code Name

Electrode, Needle, Diagnostic Electromyograph

Public Device Record Key

6bddadcf-7ecb-4a6d-a0d4-408de8148122

Public Version Date

December 29, 2020

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-