Catalog Number

-

Brand Name

Technomed Europe

Version/Model Number

4014-00

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

GXZ

Product Code Name

Electrode, Needle

Public Device Record Key

c8e956c8-442e-43f2-bcf5-f54b9c60c175

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 14, 2021

Package DI Number

08718375869642

Quantity per Package

1

Contains DI Package

08718375869635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch