Catalog Number

221-18SS-550

Brand Name

Chalgren

Version/Model Number

221-18SS-550

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

3bd7608c-2dd9-4d18-8f43-423e511322ce

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

40816020020342

Quantity per Package

20

Contains DI Package

00816020020344

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box