Catalog Number

-

Brand Name

Technomed Europe

Version/Model Number

TE/L3745-335

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

ed65b504-ff4d-45ae-bd82-d2401ea8b5d4

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

08718375861202

Quantity per Package

10

Contains DI Package

08718375861745

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox