Catalog Number

-

Brand Name

AngioDynamics

Version/Model Number

45766

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

K132713,K132713

Product Code

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Public Device Record Key

a2a2c640-4c2a-4eb6-9444-f5aa68535542

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

H965457661

Quantity per Package

10

Contains DI Package

H965457660

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX