Catalog Number

504607D

Brand Name

AVANTI

Version/Model Number

504607D

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

4914af8a-b8a8-43a8-a75d-b11d9bcf5df7

Public Version Date

September 14, 2022

Public Version Number

7

DI Record Publish Date

August 01, 2016

Package DI Number

20705032010075

Quantity per Package

5

Contains DI Package

10705032010078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX