Catalog Number

-

Brand Name

Gandras® catheter

Version/Model Number

5580

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 09, 2019

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

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

d9e9c35a-8aca-4864-af38-c6c54f0bbd30

Public Version Date

October 16, 2019

Public Version Number

4

DI Record Publish Date

September 05, 2016

Package DI Number

M20655801

Quantity per Package

5

Contains DI Package

M20655800

Package Discontinue Date

October 09, 2019

Package Status

Not in Commercial Distribution

Package Type

-