Catalog Number

-

Brand Name

AngioDynamics

Version/Model Number

06597101

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051655

Product Code

DQR

Product Code Name

CANNULA, CATHETER

Public Device Record Key

aa95677e-50d5-4cb8-bd36-a1a8a0bdf66f

Public Version Date

February 08, 2021

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

H787065971015

Quantity per Package

10

Contains DI Package

H787065971010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX