Catalog Number

-

Brand Name

EchoGlo

Version/Model Number

24-4119-24

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

K171968,K171968,K171968

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

e1d9bb56-a9cf-404d-a64e-24afa9d6dfcc

Public Version Date

August 17, 2018

Public Version Number

3

DI Record Publish Date

March 19, 2018

Package DI Number

55019517086933

Quantity per Package

16

Contains DI Package

35019517086939

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON