Catalog Number

EH125-21

Brand Name

Temena

Version/Model Number

EH125-21

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Public Device Record Key

34c8750f-469d-4368-8ca0-2a52096d8d3c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-