Catalog Number

-

Brand Name

The Sequel™

Version/Model Number

MVA200

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

fd959789-c86c-4043-92c7-20044f64f4c1

Public Version Date

April 13, 2022

Public Version Number

5

DI Record Publish Date

April 04, 2016

Package DI Number

00821684073988

Quantity per Package

5

Contains DI Package

00821684058060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK