Catalog Number

221-222SS-730-1

Brand Name

Chalgren

Version/Model Number

221-222SS-730-1

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

75b0fca4-7ded-4c31-a19a-afdfd7af99b9

Public Version Date

June 04, 2021

Public Version Number

2

DI Record Publish Date

March 25, 2021

Package DI Number

00816020021204

Quantity per Package

12

Contains DI Package

00816020021198

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box