Catalog Number

EH095-21

Brand Name

Temena

Version/Model Number

EH095-21

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

91f84df1-8937-467f-a1d9-5c59126ef7f4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 20, 2017

Package DI Number

03700339704279

Quantity per Package

10

Contains DI Package

03700339714278

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10