Catalog Number

504625Z

Brand Name

AVANTI

Version/Model Number

504625Z

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

-

Product Code

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Public Device Record Key

d3952d24-034f-418d-a75c-97205bee398c

Public Version Date

September 14, 2022

Public Version Number

7

DI Record Publish Date

August 01, 2016

Package DI Number

20705032010310

Quantity per Package

5

Contains DI Package

10705032010313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX