Catalog Number

TVI-07

Brand Name

Transvalvular Insertion Tool (TVI)

Version/Model Number

00884450544105

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Public Device Record Key

8f563d71-96a6-467f-bef7-1e6091f5dc12

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 28, 2021

Package DI Number

10884450544102

Quantity per Package

5

Contains DI Package

00884450544105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-