Catalog Number

-

Brand Name

AngioDynamics

Version/Model Number

05500101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

0400010d-df47-4747-baa9-bb9971d457d3

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

H787055001012

Quantity per Package

10

Contains DI Package

H787055001011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX