Catalog Number

110-637

Brand Name

Chalgren

Version/Model Number

110-637

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

K912283,K912283

Product Code

IKT

Product Code Name

Electrode, Needle, Diagnostic Electromyograph

Public Device Record Key

c6a31842-6612-4341-915e-52de1e183b9f

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

00816020027015

Quantity per Package

35

Contains DI Package

00816020020016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box