Catalog Number

-

Brand Name

Technomed Europe

Version/Model Number

TE/Q95-931

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"

Yes

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

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

61a5b796-6c68-49c5-a671-e01ee5b33fb8

Public Version Date

January 10, 2019

Public Version Number

1

DI Record Publish Date

December 10, 2018

Package DI Number

08718375866108

Quantity per Package

1

Contains DI Package

08718375866092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox