Catalog Number

-

Brand Name

The Big Easy™

Version/Model Number

MVA100

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

K914046,K914046

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

7865c4a3-e122-4199-a0c1-b414344a06aa

Public Version Date

September 09, 2022

Public Version Number

7

DI Record Publish Date

April 04, 2016

Package DI Number

00821684073971

Quantity per Package

5

Contains DI Package

00821684058053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK