Chalgren - Injectable Monopolar Needle Electrode, EMG, 125mm - CHALGREN ENTERPRISES

Duns Number:085932630

Device Description: Injectable Monopolar Needle Electrode, EMG, 125mm x 23g

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More Product Details

Catalog Number

242-3125-24TP-1

Brand Name

Chalgren

Version/Model Number

242-3125-24TP-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

IKT

Product Code Name

Electrode, Needle, Diagnostic Electromyograph

Device Record Status

Public Device Record Key

0f515c35-07f9-45a2-94b7-053e36f6a49c

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

40816020020441

Quantity per Package

10

Contains DI Package

00816020020443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"CHALGREN ENTERPRISES" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 66