Catalog Number

221-222SS-535

Brand Name

Chalgren

Version/Model Number

221-222SS-535

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

27d07978-ead5-4d5d-89c0-06091239c198

Public Version Date

June 11, 2021

Public Version Number

1

DI Record Publish Date

June 03, 2021

Package DI Number

10816312025900

Quantity per Package

20

Contains DI Package

00816312025903

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box