Catalog Number

-

Brand Name

AngioDynamics

Version/Model Number

56597003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2021

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

b34ec958-7a2a-40ba-99ef-832825ddbacd

Public Version Date

October 18, 2021

Public Version Number

6

DI Record Publish Date

September 19, 2016

Package DI Number

H787565970035

Quantity per Package

10

Contains DI Package

H787565970030

Package Discontinue Date

October 15, 2021

Package Status

Not in Commercial Distribution

Package Type

BOX