Catalog Number

000451

Brand Name

Bard® Ellik Evacuator

Version/Model Number

000451

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)

Yes

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

-

Product Code

KQT

Product Code Name

EVACUATOR, GASTRO-UROLOGY

Public Device Record Key

5bc0fcfd-e37e-4e50-8890-99b0f82d992c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 06, 2016

Package DI Number

10801741080811

Quantity per Package

10

Contains DI Package

00801741080814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA