Catalog Number

-

Brand Name

Technomed Europe

Version/Model Number

TE/S50725-004

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

e4117c6c-f335-4b58-ac63-fc2bdcf77418

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Package DI Number

08718375867358

Quantity per Package

12

Contains DI Package

08718375867365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox