Catalog Number

-

Brand Name

NA

Version/Model Number

9626340

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

K024316,K024316

Product Code

IKN

Product Code Name

Electromyograph, diagnostic

Public Device Record Key

227ce9e1-6561-4bd2-acb5-ab7b093a6dd6

Public Version Date

February 26, 2021

Public Version Number

3

DI Record Publish Date

March 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-