Catalog Number

-

Brand Name

EchoTuohy Epidural Needle

Version/Model Number

E3-2150-18

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

K961152,K961152

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Public Device Record Key

e1e22a50-0034-48de-a5ac-eef446a65c86

Public Version Date

June 03, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

14526737171071

Quantity per Package

10

Contains DI Package

04526737171074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-